Source: http://www.google.com/patents/US8168620?dq=inassignee:doubleclick
Timestamp: 2015-04-27 05:20:20
Document Index: 729519141

Matched Legal Cases: ['Application No. 2', 'Application No. 10', 'Application No. 2005', 'art 2', 'Application No. 762', 'art 2']

Patent US8168620 - Combination of azelastine and steroids - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or...http://www.google.com/patents/US8168620?utm_source=gb-gplus-sharePatent US8168620 - Combination of azelastine and steroidsAdvanced Patent SearchPublication numberUS8168620 B2Publication typeGrantApplication numberUS 10/518,016Publication dateMay 1, 2012Filing dateJun 13, 2003Priority dateJun 14, 2002Also published asCA2489427A1, CA2489427C, CA2779630A1, CA2779630C, CA2779633A1, CN1674910A, DE60327203D1, EP1519731A1, EP1519731B1, EP2072051A1, EP2072051B1, EP2075000A1, US8163723, US8304405, US8318709, US8933060, US8937057, US20060025391, US20090291143, US20090318397, US20100331289, US20130029951, US20130029952, WO2003105856A1Publication number10518016, 518016, US 8168620 B2, US 8168620B2, US-B2-8168620, US8168620 B2, US8168620B2InventorsAmar Lulla, Geena MalhotraOriginal AssigneeCipla LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (105), Non-Patent Citations (243), Referenced by (2), Classifications (18), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetCombination of azelastine and steroids
US 8168620 B2Abstract
A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
Sr. No. Ingredients Quantity in mcg Azelastine Hydrochloride 140 Fluticasone Valerate 50 HFA 134a q.s. Alcohol (up to 5%) Insufflatable Powders Containing Azelastine and Steroid:
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS2837464Jan 11, 1955Jun 3, 1958Schering CorpProcess for production of dienes by corynebacteriaUS3067197Apr 26, 1961Dec 4, 1962Pfizer & Co C11-oxygenated 6alpha-fluoro-16-methylene-delta-pregnenes and derivativesUS3312590Jun 9, 1964Apr 4, 1967Glaxo Lab LtdTopically active anti-inflammatory 17-mono- and 17,21-diesters of betamethasone and its 9-chloro-analogs, compositions and use thereofUS3506694Nov 27, 1967Apr 14, 1970Boots Pure Drug Co Ltd17-acyloxysteroids and their manufactureUS3557162Jan 23, 1969Jan 19, 1971Koninklijke Gist SpiritusProcess for the preparation of 17alpha-monoesters of 11beta,17alpha,21-trihydroxysteroidsUS3639434Feb 2, 1967Feb 1, 1972Boots Pure Drug Co Ltd17-acyloxysteroids and their manufactureUS3755302Jun 22, 1970Aug 28, 1973Warner Lambert PharmaceuticalProcess for the production of 17-monesters of 17{60 , 21-dihydroxy-steroids and products thereofUS3828080Jan 20, 1972Aug 6, 1974Glaxo Lab LtdAndrostane-17beta-carboxylic acids and processes for the preparation thereofUS3856828Jul 16, 1973Dec 24, 1974Glaxo Lab LtdAnti-inflammatory steroids of the androstane series having a halo-substituted c{11 {14 c{11 {11 alkoxy carbonyl group at the 17{62 {0 positionUS3891631Aug 10, 1973Jun 24, 1975Glaxo Lab LtdProcess for preparing 17{60 -monoesters of 17{60 , 21-dihydroxy-20-oxo steroidsUS3981894Aug 29, 1975Sep 21, 1976Glaxo Laboratories LimitedChemical compoundsUS3989686Sep 13, 1974Nov 2, 1976Glaxo Laboratories LimitedAnaesthetic steroids of the androstane series and process for preparing sameUS4093721Jan 6, 1977Jun 6, 1978Glaxo Laboratories LimitedPharmaceutical compositions of 6α,9α-difluoro-androst-4-ene-17β-carboxylates and derivatives thereofUS4113680Mar 29, 1976Sep 12, 1978Taisho Pharmaceutical Co., Ltd.Method for preparing 17 α-ester-21-halo pregnanesUS4187301Apr 5, 1978Feb 5, 1980Syntex (U.S.A.) Inc.17 Beta-thiocarboxylic acid esters of 6 alpha, 6 beta-difluoro-3-oxoandrost-4-enesUS4188385Apr 5, 1978Feb 12, 1980Syntex (U.S.A.) Inc.Thioetianic acid derivativesUS4198403Apr 5, 1978Apr 15, 1980Syntex (U.S.A.) Inc.17 Beta-thiocarboxylic acid esters of 4-halo-3-oxoandrost-4-enesUS4221787Jul 20, 1979Sep 9, 1980Interx Research CorporationEsteramide prodrugs of anti-inflammatory corticosteroidsUS4261984Aug 29, 1979Apr 14, 1981Syntex (U.S.A.) Inc.Antiinflammatory steroidsUS4263289Aug 31, 1979Apr 21, 1981Syntex (U.S.A.) Inc.Antiinflammatory steroidsUS4267173Nov 5, 1979May 12, 1981Schering CorporationUse of 6β-fluoro-7α-halogenocorticoids as topical anti-inflammatories and pharmaceutical formulations useful thereforUS4285937Oct 30, 1979Aug 25, 1981Ciba-Geigy CorporationNovel androstadiene-17-carboxylic acid estersUS4310466Nov 7, 1980Jan 12, 1982Syntex (U.S.A.) Inc.Antiinflammatory steroidsUS4335121Feb 13, 1981Jun 15, 1982Glaxo Group LimitedAndrostane carbothioatesUS4377575Dec 15, 1980Mar 22, 1983Hoechst AktiengesellschaftAntiinflammatory dermatitisUS4472393Jul 29, 1982Sep 18, 1984Schering Corporation3,20-Dioxo-1,4-pregnadiene-17α-ol 17-aromatic heterocycle carboxylatesUS4607028Aug 9, 1984Aug 19, 1986Ciba-Geigy CorporationAntiinflammatory agentsUS4710495Apr 8, 1985Dec 1, 1987Otsuka Pharmaceutical Co., Ltd.Soft steroids having anti-inflammatory activityUS4861765Jun 23, 1986Aug 29, 1989Jouveinal21-alkyl-, cycloalkyl- or aryl-substituted thio steroids and pharmaceutical compositions containing themUS4992474Aug 23, 1989Feb 12, 1991Glaxo Group Ltd.Phenethanolamine derivativesUS4994439Jan 19, 1989Feb 19, 1991California Biotechnology Inc.Transmembrane formulations for drug administrationUS4996335Dec 9, 1985Feb 26, 1991Nicholas S. BodorSoft steroids having anti-inflammatory activityUS5063222Apr 13, 1990Nov 5, 1991Ss Pharmaceutical Co., Ltd.Antiinflammatory dexamethasone 17α-cyclopropanecarboxylates with reduced systemic activityUS5081113Mar 21, 1990Jan 14, 1992Roussel UclafNovel 3-keto-steroidsUS5164194Jul 12, 1990Nov 17, 1992Asta Pharma AgTreatment of irritated eye and nose mucous membranes resulting from a cold or allergyUS5202316Oct 9, 1991Apr 13, 1993Roussel UclafN,N,N',N'-6-(1-piperazinyl)-2,5-pyridinediaminesUS5232919Oct 15, 1990Aug 3, 1993Asta Pharma AktiengesellschaftAntiallergens; treating asthma; liquid phase, suspensions, tasteUS5271946Apr 10, 1992Dec 21, 1993Asta Pharma AktiengesellschaftControlled release azelastine-containing pharmaceutical compositionsUS5362721Feb 8, 1993Nov 8, 1994Hoechst AktiengesellschaftCorticoid-17-alkyl-carbonates substituted in the 17-position, process for their preparation and pharmaceuticals containing themUS5420120Dec 17, 1993May 30, 1995Alcon Laboratories, Inc.Anti-inflammatory glucocorticoid compounds for topical ophthalmic useUS5608093Aug 25, 1994Mar 4, 1997Hoechst AktiengesellschaftCorticosteroid 17-alkyl carbonate 21-[0]-carboxylic and carbonic esters, and pharmaceuticals containing these compoundsUS5658549May 19, 1995Aug 19, 1997Glaxo Group LimitedInhalating drug comprising tetrafluoroethane/1,1,1,2-/ for treating respiratory system disorderUS5658919Sep 9, 1996Aug 19, 1997Mcneil-Ppc, Inc.Liquid acetaminophen mixture comprising at least one additional active drug, a suspending system and a taste masking compositionUS5707984Dec 8, 1995Jan 13, 1998G. D. Searle & Co.Smooth muscle relaxantsUS5837699Mar 20, 1997Nov 17, 1998Schering CorporationHigh speed asthma and allergic rhinitis treatment; side effect reductionUS5849265Sep 27, 1995Dec 15, 1998Glaxo Wellcome Inc.Pharmaceutical aerosol formulation comprising a medicament, a propellant and a fluorinated surfactantUS5889015Aug 14, 1997Mar 30, 1999Schering CorporationAntiallergens, antihistamineUS5914122Jun 27, 1997Jun 22, 1999Dr. Falk Pharma GmbhStable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foamsUS5972920Feb 12, 1998Oct 26, 1999Dermalogix Partners, Inc.Formulation containing a carrier, active ingredient, and surfactant for treating skin disordersUS5981517Apr 24, 1997Nov 9, 1999Soft Drugs, Inc.Androstene derivativesUS6017963 *Nov 14, 1995Jan 25, 2000Euro-Celtique, S.A.Formulation for intranasal administrationUS6057307Mar 1, 1999May 2, 2000Schering CorporationUse of mometasone furoate for treating airway passage and lung diseasesUS6127353Sep 6, 1991Oct 3, 2000Schering CorporationMometasone furoate monohydrate, process for making same and pharmaceutical compositionsUS6136294Sep 22, 1998Oct 24, 2000Aeropharm Technology Inc.Amino acid stabilized medical aerosol formulationUS6197761Dec 19, 1996Mar 6, 2001Glaxo Wellcome Inc.17β-2-oxo-tetrahydrofuranyl)-carbothioic acid ester, -carboxylic acid ester and -carboxylic acid amide androstane derivativesUS6261539Dec 10, 1998Jul 17, 2001Akwete AdjeiMedicine, propellants, stabilizers and dispersantsUS6294153 *Sep 16, 1999Sep 25, 2001Generex Pharmaceuticals, Inc.Aerosol pharmaceutical formulation for pulmonary and nasal deliveryUS6319513Jul 27, 1999Nov 20, 2001The Procter & Gamble CompanyOral liquid mucoadhesive compoundsUS6330938Jun 15, 1999Dec 18, 2001Automobile, PeugeotMethod and device for controlling an electric actuator activating a functional systemUS6391340 *Nov 3, 1999May 21, 2002Astrazeneca AbDry powder pharmaceutical formulationUS6395300Nov 4, 1999May 28, 2002Acusphere, Inc.Drugs having low solubility, formulations of such drugs to enhance their rate of dissolutionUS6416743 *Aug 30, 2000Jul 9, 2002Schering CorporationNontoxic, stable formulation free of chlorofluorocarbons; surfactant and excipient freeUS6525228Oct 22, 2001Feb 25, 2003Celanese Chemicals Europe GmbhProcess of telomerizing conjugated dienesUS6537983Feb 4, 2002Mar 25, 2003Smithkline Beecham CorporationAnti-inflammatory androstane derivativesUS6583180 *Feb 8, 2002Jun 24, 2003Abbott LaboratoriesGlucocorticoid receptor modulatorsUS6787532Feb 4, 2002Sep 7, 2004Smithkline Beecham CorporationFormulation containing anti-inflammatory androstane derivativesUS6921757Jun 26, 2001Jul 26, 2005Novartis AgConversion of carboxylic acid substituent in a gonane ring, into the methyl ester, or hydrochlorination of a 9-11-epoxy-9-H-cyclopenta(a)phenanthrene compoundsUS7101866Aug 3, 2001Sep 5, 2006Glaxo Group Limited6,9-Difluoro-17 alpha -((2-furanylcarbonyl)oxy)-11 beta -hydroxy-16 alpha -methyl-3-oxo-androsta-1,4-diene-17 beta -carbothioic acid S-fluoromethyl ester; antiinflammatory agents for the treatment of allergic conditionsUS7244742Jul 23, 2003Jul 17, 2007Boehringer Ingelheim Pharma Gmbh & Co KgPharmaceutical compositions for inhalation containing an anticholinergic, corticosteroid and betamimeticUS7776315Dec 8, 2004Aug 17, 2010Boehringer Ingelheim Pharma Gmbh & Co. KgPharmaceutical compositions based on anticholinergics and additional active ingredientsUS20020061281Aug 31, 2001May 23, 2002Osbakken Robert S.Aerosolized anti-infectives, anti-inflammatories, and decongestants for the treatment of sinusitisUS20020076382Aug 1, 2001Jun 20, 2002Kaplan Leonard W.As well as drug delivery devices and dosage formsUS20020081266Aug 14, 2001Jun 27, 2002Norton Healthcare Ltd.Spray dried powders for pulmonary or nasal administrationUS20020103392Jul 22, 1997Aug 1, 2002Ulrich StacheCorticoid-17,21-dicarboxylic esters and corticosteroid 17-carboxylic ester 21-carbonic esters, processes for their preparation and pharmaceuticals containing these compoundsUS20020165211Feb 4, 2002Nov 7, 2002Keith BiggadikeAqueous suspension of Fluticasone furoate; respiratory tract disorders; asthma, COPD; antiinflammatory, antiallergen; nasal inhalerUS20020173496Feb 4, 2002Nov 21, 2002Keith BiggadikeFormulation containing novel anti-inflammatory androstane derivativeUS20020177581Feb 4, 2002Nov 28, 2002Keith BiggadikeNovel anti-inflammatory androstane derivativeUS20030018019Jun 17, 2002Jan 23, 2003Boehringer Ingelheim Pharma KgPharmaceutical compositions based on anticholinergics, corticosteroids and betamimeticsUS20030073676Feb 4, 2002Apr 17, 2003Keith BiggadikeDissolving in aqueous carrier; antiallergensUS20030109511Jul 22, 2002Jun 12, 2003Keith BiggadikeNovel anti-inflammatory androstane derivative compositionsUS20030144257Sep 11, 2002Jul 31, 2003Keith BiggadikeAdministering to a human or animal for inflammation/allergies 6-alpha-9-alpha-difluoro-17 alpha-(2-furanylcarbonyl)oxy)-11 beta-hydroxy-16-alpha-methyl-3-oxo-androsta-1,4-diene-17 beta-carbothioic acid-s-fluoromethyl esterUS20030158163Jun 26, 2001Aug 21, 2003Bernard CuenoudConversion of carboxylic acid substituent in a gonane ring, into the methyl ester, or hydrochlorination of a 9-11-epoxy-9-H-cyclopenta(a)phenanthrene compoundsUS20040053904Dec 21, 2001Mar 18, 2004Teruo Komoto9-fluoro-11 beta-hydroxy-16 alpha-methyl-1,4-pregnadiene-3,20-dione 17-cyclopropanecarboxylate derivative for the treatment of respiratory system disorders such as bronchial asthmaUS20040136918Mar 4, 2002Jul 15, 2004Garrett Ronique Nichelesalmeterol xinafoate and fluticasone propionate in a metered does inhaler with propellantUS20040204399Apr 29, 2004Oct 14, 2004Osbakken Robert S.Aerosolized decongestants for the treatment of sinusitisUS20040235807May 21, 2003Nov 25, 2004Weinrich Karl P.Administering formulation for intranasal drug administration, wherein the formulation comprises: a topically administrable decongestant;a topically administrable corticosteroid: and carrier that is suitable for nasal drug administrationUS20040242638Nov 18, 2002Dec 2, 2004Yanni John MTreatment of rhinitis with steroids as antiallergensUS20050163724Jun 13, 2003Jul 28, 2005Ssp Co., Ltd.Contains steroidal anti-inflammatory drug, carrier (saccharides, sugar alcohols, amino acids), and waterUS20050192261Sep 14, 2004Sep 1, 2005Jost-Price Edward R.Methods and reagents for the treatment of immunoinflammatory disordersUS20060110331Nov 22, 2005May 25, 2006Medpointe Healthcare Inc.Compositions comprising azelastine and methods of use thereofUS20060228306Mar 27, 2006Oct 12, 2006Fairfield Clinical Trials LlcCombination antihistamine and steroid medicationUS20070020330Jul 14, 2006Jan 25, 2007Medpointe Healthcare Inc.Compositions comprising azelastine and methods of use thereofUS20090286762Jul 26, 2007Nov 19, 2009Glaxo Group LimitedPharmaceutical Formulations Comprising Azelastine and a Corticosteroid for the Treatment of Inflammatory or Allergic ConditionsUS20090291143Jul 23, 2009Nov 26, 2009Cipla LimitedCombination of Azelastine and SteroidsUS20090318397Jul 23, 2009Dec 24, 2009Cipla LimitedCombination of Azelastine and SteroidsUS20100152147Sep 29, 2009Jun 17, 2010Meda Pharmaceuticals Inc.Compositions Comprising Azelastine and Methods of Use ThereofAU2003244799B2 Title not availableBE889563A1 Title not availableDE1059906BAug 6, 1955Jun 25, 1959Scherico LtdVerfahren zur Herstellung von 1, 4-PregnadienenDE3836579A1Oct 27, 1988May 24, 1989Asta Pharma AgAzelastine-containing pharmaceutical compositions for use in the nose and/or on the eyeDE10152369A1Oct 24, 2001May 8, 2002Boehringer Ingelheim PharmaStable, propellant-free inhalable liquid medicament for treating asthma or chronic obstructive pulmonary disease, containing tiotropium salt and antiallergic agent, antihistamine, steroid or leukotriene antagonistDE19947234A1Sep 30, 1999Apr 5, 2001Asta Medica AgNeue Kombination von Loteprednol und AntihistaminikaEP0004773A2Apr 3, 1979Oct 17, 1979Syntex (U.S.A.) Inc.17-Beta-thiocarboxylic acid esters of 4-halo-3-oxoandrost-4-enes, their pharmaceutical use and processes for their preparationEP0057401A1Jan 25, 1982Aug 11, 1982Schering CorporationAromatic heterocyclic esters of steroids, their preparation and pharmaceutical compositions containing themEP0780127A1 *Dec 5, 1996Jun 25, 1997THE PROCTER &amp; GAMBLE COMPANYA nasal spray containing a steroid and a antihistamine* Cited by examinerNon-Patent CitationsReference1"Azelastine," STN Registry No. 58581-89-8, STN Registry File, Retrieved Nov. 23, 2010, p. 1.2"Fluticasone Furoate," STN Registry No. 397864-44-7, STN Registry File, Retrieved Nov. 23, 2010, p. 1.3ABPI Compendium of Data Sheets and Summaries of Product Characteristics, 1999-2000, Cover page, p. 43 and Index p. 1882, Datapharm Publications Limited, London, Great Britain.4ABPI Data Sheet Compendium, 1995-96, cover page plus pp. 38-39, Datapharm Publications Limited, London, Great Britain.5Aigbirhio, Franklin I., et al., "Automated radiosynthesis of no-carrier-added [S-fluoromethy1-18F]Fluticasone propionate as a radiotracer for lung deposition studies with PET," Journal of Labelled Compounds and Radiopharmaceuticals, vol. 39, No. 7, 1997, pp. 569-584.6Akerlund, Anders, et al., "Clinical trial design, nasal allergen challenge models, and considerations of relevance to pediatrics, nasal polyposis, and different classes of medication," J. Allergy Clin. Immunol., Mar. 2005, vol. 115, No. 3, pp. S460-S482.7Applicant Response to foreign communication EP Patent 1519731, Aug. 11, 2011, 252 pages.8Applicants' response dated Feb. 24, (2010) 2011 (8 pages) in U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.9Applicants' response dated Jun. 22, 2011 (9 pages) in U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.10Applicants' response dated Oct. 6, 2010 (8 pages) in U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.11Applicants' response dated Sep. 6, 2011 (8 pages) in U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.12Applicants response to foreign communication-CA 2489427, Dec. 20, 2010, 10 pages.13Applicants response to foreign communication�CA 2489427, Dec. 20, 2010, 10 pages.14Applicants response to foreign communication-EP 03738280.1 (EP Patent 1519731) , Sep. 6, 2010, 15 pages.15Applicants response to foreign communication�EP 03738280.1 (EP Patent 1519731) , Sep. 6, 2010, 15 pages.16Applicants response to foreign communication-EP 03738280.1, Jan. 18, 2008, 17 pages.17Applicants response to foreign communication�EP 03738280.1, Jan. 18, 2008, 17 pages.18Applicants response to foreign communication-EP 03738280.1, May 22, 2006, 36 pages.19Applicants response to foreign communication�EP 03738280.1, May 22, 2006, 36 pages.20Applicants response to foreign communication-KR10-2004-7020819, Dec. 27, 2010, 18 pages.21Applicants response to foreign communication�KR10-2004-7020819, Dec. 27, 2010, 18 pages.22Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, U.S. Physicians Desk Reference, pp. 1876-1877.23Astepro (azelastine HCI) Nasal Spray 0.15%, Meda Pharmaceuticals Inc., 2009, Press Release, pp. 1-4.24Aurora, Jack, "Nasal Delivery; Development of Nasal Delivery Systems: A Review," Drug Delivery Technology, vol. 2, No. 7, Oct. 2002, 8 pages, http://www.drugdelivelytech.com/ME2/Segments/Publications: Article&id=9EB19EB2F29F462089CE081473F5F3CA.25Austin, et al., "Mometasone furoate is a less specific glucocorticoid than fluticasone propionate," Eur. Respir. J., 2002, vol. 20, pp. 1386-1392.26Avicel� RC/CL, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, NF Dispersible Cellulose, BP, Specifications and Analytical Methods, RC-16 Updated Oct. 1995 (Feb. 1999), 6 pages, FMC BioPolymer.27Baena-Cagnani, Carlos E., "Safety and Tolerability of Treatments for Allergic Rhinitis in Children," Drug Safety 2004, vol. 27, No. 12, pp. 883-898, ADIS Data Information BV.28Banov, et al., "Once daily intranasal fluticasone propionate is effective for perennial allergic rhinitis," Annals of Allergy, 1994, vol. 73, pp. 240-246.29Barnes, M. L., et al., "Effects of levocetirizine as add-on therapy to fluticasone in seasonal allergic rhinitis," Clinical and Experimental Allergy, Jan. 27, 2006, vol. 36, pp. 676-684, Blackwell Publishing Ltd.30Barnes, Peter J., "Chronic obstructive pulmonary disease: new opportunities for drug development," Trends in Pharmacological Sciences, vol. 19, No. 10, 1998, pp. 415-423.31Barnes, Peter J., "Efficacy of inhaled corticosteroids in asthma," The Journal of Allergy and Clinical Immunology, vol. 102, No. 4, 1998, pp. 531-538, 1998.32Barnes, Peter J., "Novel approaches and targets for treatment of chronic obstructive pulmonary disease," American Journal of Respiratory and Critical Care Medicine, vol. 160, 1999, pp. S72-S79.33Baumgarten, C., et al., "Initial treatment of symptomatic mild to moderate bronchial asthma with the salmeterol/fluticasone propionate (50/250μg) combination product (SAS 40023)," European Journal of Medical Research, 2002, vol. 7, pp. 1-7.34Berge, Stephen M., et al., "Pharmaceutical Salts," Journal of Pharmaceutical Sciences, vol. 66, No. 1, Jan. 1977, pp. 1-19.35Berstein, et al., "Treatment with intranasal fluticasone propionate significantly improves ocular symptons in patients with seasonal allergic rhinitis," Clin. Exp. Allergy, 2004, vol. 34, pp. 952-957.36Biggadike, Keith, Letter to the Editor, "Fluticasone furoate/fluticasone propionate-different drugs with different properties," The Clinical Respiratory Journal, 2011, pp. 183-184.37Biggadike, Keith, Letter to the Editor, "Fluticasone furoate/fluticasone propionate�different drugs with different properties," The Clinical Respiratory Journal, 2011, pp. 183-184.38Block, John H., et al., "Inorganic Medicinal and Pharmaceutical Chemistry," 1986, cover, publication, and preface pages plus p. 100, Indian Edition, Varghese Publishing House, Bombay, India.39Bowler, Simon, "Long acting beta agonists," Australian Family Physician, vol. 27, No. 12, 1998, pp. 1115, 1117-1118, plus cover.40Brooks, et al', "Spectrum of seasonal allergic rhinitis symptom relief with topical corticoid and oral antihistamine given singly or in combination," American Journal of Rhinology, 1996, vol. 10, No. 3, pp. 193-199.41Bryson, et al., "Intranasal fluticasone propionate: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis," Drugs, 1992, vol. 43, No. 5, pp. 760-775.42Busse W W et al: "Corticosteroid-Sparing Effect of Azelastine in the Management of Bronchial Asthma"-American Journal of Respiratory and Critical Care Medicine, American Lung Association, new York, NW, vol. 153, No. 1, 1996, pp. 122-172, p. 127, col. 1, paragraph 2.43Busse W W et al: "Corticosteroid-Sparing Effect of Azelastine in the Management of Bronchial Asthma"�American Journal of Respiratory and Critical Care Medicine, American Lung Association, new York, NW, vol. 153, No. 1, 1996, pp. 122-172, p. 127, col. 1, paragraph 2.44Busse, William, et al., "Steroid-sparing effects of fluticasone propionate 100μg and salmeterol 50 μg. administered twice daily in a single product in patients previously controlled with fluticasone propionate 250 μg administered twice daily," J. Allergy Clin. Immunol., vol. 111, No. 1, Jan. 2003, pp. 57-65.45CAS Registry No. 102113-40-6, 2004.46CAS Registry No. 90566-53-3, "Fluticasone," Nov. 16, 1984.47Chapman, et al., "Anti-inflammatory activity of inhaled mometasone furoate in allergic mice," Arzneimettelforschung ("Drug Research"), 1998, vol. 48, No. 4, pp. 384-391.48CIPLA Annual Report Extract; 2010; (report shows that they launched an FF+azelastine product in 2010).49Cipla Sixty-Ninth Annual Report 2004-2005, cover pages, information page, plus pp. 3, 5, and 44.50CIPLA's response to Statement of Opposition for EP1519731, 2011.51Comparative data of azelastine with steroids, 2011.52Daley-Yates, et al., "Systemic bioavailability of fluticasone propionate administered as nasal drops and aqueous nasal spray formulations," Br. J. Clin. Pharmocol., 2001, vol. 51, pp. 103-105.53Database Medline Online! US National Library of Medicine (NLM), Bethesda, MD, US: 2000 Portmann D et al: Acceptability of local treatment of allergic rhinitis with a combination of a corticoid (beclomethasone) and an antihistaminic (azelastine); vol. 121, No. 4, 2000, pp. 273-279.54Declaration of Geena Malhotra for EP1519731 dated Aug. 11, 2011.55Declaration of Joachim Maus for EP1519731 dated Aug. 10, 2011.56Derby, et al., "Risk of cataract among users of intranasal corticosteroids," J. Allergy Clin. Immunol., 2000, vol. 105, No. 5, pp. 912-916.57Dewester, et al., "The efficacy of intranasal fluticasone propionate in relief of ocular symptoms associated with seasonal rhinitis," Allergy and Asthma Proc., 2003, vol. 24, No. 5, pp. 331-337.58Di Lorenzo, G., et al., "Randomized Placebo-controlled Trial Comparing fluticasone aqueous nasal spray in mono-therapy, fluticasone plus cetirizine, fluticasone plus montelukast and cetirizine plus montelukast for seasonal allergic rhinitis," Clin. Exp. Allergy, 2004, vol. 34, pp. 259-267, Blackwell Publishing Ltd.59Dictionary of Organic Compounds, 6th Ed., vol. 1, p. 3234, definition of "fluticasone," Chapman & Hall, 1996.60Dolovich, et al., "Multicenter trial of fluticasone propionate aqueous nasal spray in ragweed allergic rhinitis," Annals of Allergy, 1994, vol. 73, No. 2, pp. 147-153.61Drouin, Michel A., et al., "Adding Loratadine to Topical Nasal Steroid Therapy Improves Moderately Severe Seasonal Allergic Rhinoconjunctivitis," Advances in Therapy, vol. 12, No. 6, Nov./Dec. 1995, pp. 340-349, Health Communications Inc.62Duonase Data Sheet, "The complete rhinitis control," 6 pages, Cipla Limited, Mumbai, India, 2004.63Dykewicz, Mark S., et al., "Diagnosis and Management of Rhinitis: Complete Guidelines of the Joint Task Force on Practice Parameters in Allergy, Asthma and Immunology," Annals of Allergy, Asthma, & Immunology, vol. 81, November (Part II) 1998, pp. 478-518.64File history of Australian Patent Application No. AU2003244799, 38 pages.65File history of Brazilian Patent Application No. PI 0312128-3, 27 pages, Apr. 2011.66File history of Canadian Patent Application No. 2,489,427, 19 pages, Dec. 2010.67File history of Korean Patent Application No. 10-2004-7020819, 89 pages.68File history of Mexican Patent Application No. PA/a/2004/01266 (now Patent No. 265349), 86 pages.69File history of Polish Patent Application No. P-373001, 95 pages, May 2011.70File history of Russian Patent Application No. RU 2361593 C2, 65 pages, Apr. 2009.71File history of South African Patent Application No. 2005/0331 (now Patent No. 2005/0331), 18 pages.72Foreign communication from a related counterpart application-AU2003244799, Examination Report, Nov. 20, 2007, 2 pages.73Foreign communication from a related counterpart application�AU2003244799, Examination Report, Nov. 20, 2007, 2 pages.74Foreign communication from a related counterpart application-CA2,489,427, Examination Report, Jun. 18, 2010, 3 pages.75Foreign communication from a related counterpart application�CA2,489,427, Examination Report, Jun. 18, 2010, 3 pages.76Foreign communication from a related counterpart application-CA2,489,427, Examination Report, Mar. 24, 2011, 2 pages.77Foreign communication from a related counterpart application�CA2,489,427, Examination Report, Mar. 24, 2011, 2 pages.78Foreign communication from a related counterpart application-Examination Report, EP Application 03738280.1, Jul. 18, 2007, 5 pages.79Foreign communication from a related counterpart application�Examination Report, EP Application 03738280.1, Jul. 18, 2007, 5 pages.80Foreign communication from a related counterpart application-Examination Report, EP Application 03738280.1, Nov. 10, 2005, 4 pages.81Foreign communication from a related counterpart application�Examination Report, EP Application 03738280.1, Nov. 10, 2005, 4 pages.82Foreign communication from a related counterpart application-Examination Report, RU 2005100781, Apr. 23, 2007, 6 pages.83Foreign communication from a related counterpart application�Examination Report, RU 2005100781, Apr. 23, 2007, 6 pages.84Foreign communication from a related counterpart application-Examination Report, RU 2005100781, May 23, 2008, 3 pages.85Foreign communication from a related counterpart application�Examination Report, RU 2005100781, May 23, 2008, 3 pages.86Foreign communication from a related counterpart application-KR 10-2004-7020819, Examination Report, Aug. 26, 2010, 8 pages.87Foreign communication from a related counterpart application�KR 10-2004-7020819, Examination Report, Aug. 26, 2010, 8 pages.88Foreign communication from a related counterpart application-Notice of Intent to Grant, EP Application 03738280.1, Oct. 23, 2008, 6 pages.89Foreign communication from a related counterpart application�Notice of Intent to Grant, EP Application 03738280.1, Oct. 23, 2008, 6 pages.90Foreign communication from a related counterpart application-Notice of Opposition, EP Application 03738280.1, Feb. 22, 2010, 22 pages.91Foreign communication from a related counterpart application�Notice of Opposition, EP Application 03738280.1, Feb. 22, 2010, 22 pages.92Foreign communication from a related counterpart application-Summons to Attend Oral Proceedings, EP Application 03738280.1, Feb. 8, 2011, 1 page.93Foreign communication from a related counterpart application�Summons to Attend Oral Proceedings, EP Application 03738280.1, Feb. 8, 2011, 1 page.94Foreign communication from a related counterpart application-Translation of Office Action, Israel Patent Application 165771, Jul. 11, 2011, 3 pages.95Foreign communication from a related counterpart application�Translation of Office Action, Israel Patent Application 165771, Jul. 11, 2011, 3 pages.96Foreign communication from the priority application-International Preliminary Examination Report, PCT/GB03/02557, Aug. 26, 2004, 6 pages.97Foreign communication from the priority application�International Preliminary Examination Report, PCT/GB03/02557, Aug. 26, 2004, 6 pages.98Foreign communication from the priority application-International Search Report, PCT/GB03/02557, Sep. 17, 2003, 3 pages.99Foreign communication from the priority application�International Search Report, PCT/GB03/02557, Sep. 17, 2003, 3 pages.100Fowler, Stephen J., et al., "Step-down therapy with low-dose fluticasone-salmeterol combination or medium-dose hydrofluoroalkane 134a-beclomethasone alone," J. Allergy Clin. Immunol., vol. 109, No. 6, Jun. 2002, pp. 929-935.101Galant, Stanley P., et al., "Clinical Prescribing of Allergic Rhinitis Medication in the Preschool and Young School-Age Child, What are the Options?," BioDrugs2001, vol. 15, No. 7, pp. 453-463, ADIS International Ltd.102Garner, R. C., et al., "A validation study comparing accelerator MS and liquid scintillation counting for analysis of 14C-labelled drugs in plasma, urine and faecal extracts," Journal of Pharmaceutical and Biomedical Analysis, vol. 24, 2000, pp. 197-209.103Gawchik, et al., "Comparison of intranasal triamcinolone acetonide with oral loratadine in the treatment of seasonal ragweed-induced allergic rhinitis," Am. J. Man. Care, 1997, vol. 3, No. 7, pp. 1052-1058.104Gennaro, Alfonso R., ed., et al., Remington: The Science and Practice of Pharmacy, 2000, 20th edition, vol. 1, pp. 785, 830, 831 plus cover page and publication page, Lippincott Williams & Wilkins.105Gilbert, Peter, et al., "Preservation of pharmaceutical products," Encyclopedia of Pharmaceutical Technology, 2002, 2nd edition, vol. 3, p. 2278 plus cover page and publication page, Marcel Dekker, Inc.106Hampel, Frank C., et al., Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device, Annals of Allergy, Asthma & Immunology, Aug. 2010, vol. 105, pp. 168-173.107Harding, "The human pharmacology of fluticasone propionate," Respiratory Medicine, 1990, vol. 84, Suppl. A, pp. 25-29.108Herrero, Vanrell, R., "Preservatives in Ophthalmic Formulations: An Overview," Arch. Soc. Esp. Oftalmol, 2007, vol. 82., pp. 531-532.109Hodges, N. A., et al., "Preservative Efficacy Tests in Formulated Nasal Products: Reproducibility and Factors Affecting Preservative Activity," J. Pharm. Pharmacol., 1996, vol. 48, pp. 1237-1242.110Hodges, Norman, et al., "Antimicrobial Preservative Efficacy Testing," Handbook of Microbiological Quality Control, Pharmaceuticals and Medical Devices, 2000, p. 168 plus cover page and publication page, Rosamund M. Baird, et al., Editor, Taylor & Francis Publisher, USA and Canada.111Holgate, Stephen T., Difficult Asthma, 1999, cover page and publishing information.112Howarth, P. H., "A comparison of the anti-inflammatory properties of intranasal corticosteroids and antihistamines in allergic rhinitis," Allergy 2000, vol. 62, pp. 6-11, Munksgaard 2000.113Howland, "Fluticasone propionate: topical or systemic effects?" Clinical and Experimental Allergy, 1996, vol. 26, Suppl. 3, pp. 18-22.114International Search Report under Section 17 UK Patent Office collections, including GB, EP, WO & US patent specifications.115Isogai, et al., "Binding affinities of mometasone furoate and related compounds including its metabolites for the glucocorticoid receptor of rat skin tissue," J. Steroid Biochem. Mol. Biol., 1993, vol. 44, pp. 141-145.116Johansson, Gunnar, et al., "Comparison of salmeterol/fluticasone propionate combination with budesonide in patients with mild-to-moderate asthma," Clin. Drug Invest., vol. 21, No. 9, 2001, pp. 633-642, 11 pages.117Johnson, Malcom, "Development of fluticasone propionate and comparison with other inhaled corticosteroids," J. Allergy Clin. Immunol., Apr. 1998, vol. 101, No. 4, Part 2, pp. S434-S439.118Juniper, E F., et al., "Comparison of beclomethasone dipropionate aqueous nasal spray, astemizone, and the combination in the prophylactic treatment of ragweed pollen-induced rhinoconjunctivitis," Journal of Allergy and Clinical Immunology, Mar. 1989, vol. 83, No. 3, Cover page, Publications page, pp. 627-633, American Academy of Allergy and Immunology, C.V. Mosby Co.119Juniper, Elizabeth F., et al., "Impact of inhaled salmeterol/fluticasone propionate combination product versus budesonide on the health-related quality of life of patients with asthma," Am. J. Respir. Med., vol. 1, No. 6, 2002, pp. 435-440.120Kenley, Richard A., et al., "An automated, column-switching HPLC method for analyzing active and excipient materials in both cream and ointment formulations," Drug Development and Industrial Pharmacy, vol. 11 (9 & 10), 1985, pp. 1781-1796.121Kertesz, Denis J., et al., "Thiol esters from steroid 17β-carboxylic acids: carboxylate activation and internal participation by 17 α-acylates," J. Org. Chem., vol. 51, 1986, 14 pages.122Knobil, K., et al., "Adding salmeterol is more effective than increasing the dose of fluticasone for patients with asthma who are symptomatic on low dose fluticasone," European Respiratory Review, Copenhagen, DK, vol. 12, Suppl. 29, Dec. 1998 (1998-12), pp. 19S-20S.123Kooreman, et al., "The synthesis of 17-esters of corticosteroids protection of 11β-hydroxyl of the trimethylsilyl group," Synthetic Communications, vol. 1, No. 2, pp. 81-87, 1971.124Laforce, et al., "Fluticasone propionate: an effective alternative treatment for seasonal allergic rhinitis in adults and adolescents," J. Fam. Pract., 1994, vol. 38, No. 2, pp. 145-152.125Lane, S. J., et al., "Evaluation of a new capillary electrochromatography/mass spectrometry interface using short columns and high field strengths for rapid and efficient analyses," Rapid Communications in Mass Spectrometry, vol. 10, 1996, pp. 733-736.126Lewis, Sarah A., et al., "Association of specific allergen sensitization with socioeconomic factors and allergic disease in a population of Boston women," J. Allergy Clin. Immunol., vol. 107, No. 4, Apr. 2001, pp. 615-622.127Li, et al., "Synthesis of aryl 5-(2-chlorophenyl)-2-furoates under phase transfer catalysis," Synthetic Communications, vol. 32, No. 20, pp. 3081-3086, 2002.128Linder, "Symptom scores as measurements of the severity of rhinitis," Clinical Allergy, 1988, vol. 18, pp. 29-37.129Lumry, William R., "A review of the preclinical and clinical data of newer intranasal steroids in the treatment of allergic rhinitis," Allergy Clin. Immunol., Oct. 1999, 104 (4 Pt 1), pp. S150-S158 plus one correction page.130Lutsky, et al., "A novel class of potent topical antiinflammatory agents: 17-benzolyated, 7a-halogeno substituted corticosteroids," Arzneimettelforschung ("Drug Research"), 1978, vol. 29, No. 11, pp. 1662-1667.131Lyseng-Williamson, Katherine A., et al., "Inhaled salmeterol/fluticasone propionate combination in chronic obstructive pulmonary disease," Am. J. Respir. Med., vol. 1, No. 4, 2002, pp. 273-282.132Mahoney, Janette M., et al., "Drug effects on the neovascularization response to silver nitrate cauterization of the rat cornea," Current Eye Research, vol. 4, No. 5, 1985, pp. 531-535.133Malhotra Exhibit A, Aug. 2011.134Malhotra Exhibit B, Aug. 2011.135Maus Exhibit B, Aug. 2011.136May, Percy, et al., "May's Chemistry of Synthetic Drugs," Fifth Edition, 1964, pp. 12-17, Longmans.137McNeely, Wendy, et al., "Intranasal Azelastine A Review of its Efficacy in the Management of Allergic Rhinitis," Drugs, 1998, vol. 56, No. 1, pp. 91-114.138Mealy, N. E., et al., "Ciclesonide: treatment of allergic rhinitis antiallergy/antiasthmatic," Drugs of the Future, Prous Science, ES, vol. 26, No. 11, Nov. 2001, pp. 1033-1039.139Meltzer, Eli O., "Allergic rhinitis: Managing the pediatric spectrum," Allergy and Asthma Proceedings, Jan.-Feb. 2006, vol. 27, No. 1, pp. 2-8, Oceanside Publications, Inc., USA.140Meltzer, et al., "Onset of therapeutic effect of fluticasone propionate aqueous nasal spray," Ann. Allergy Asthma Immunol., 2001, vol. 86, No. 3, pp. 286-291.141Millard, Jeffrey W., et al., "Solubilization by cosolvents establishing useful constants for the log-linear model," Int'l Journal of Pharmeceutics, vol. 245, 2002, pp. 153-166.142Mistry, Nisha, et al., "Characterisation of impurities in bulk drug batches of fluticasone propionate using directly coupled HPLC-NMR spectroscopy and HPLC-MS," Journal of Pharmaceutical and Biomedical Analysis, vol. 16, 1997, pp. 697-705.143Mistry, Nisha, et al., "Impurity profiling in bulk pharmaceutical batches using 19F NMR spectroscopy and distinction between monomeric and dimeric impurities by NMR-based diffusion measurements," Journal of Pharmaceutical and Biomedical Analysis, vol. 19, 1999, pp. 511-517.144M�llmann, H., et al., Handbook of pharmacokinetic/pharmacodynamic correlation, Chapter 14, Pharmacokinetic-Pharmacodynamic Correlations of Corticosteroids, 323-336, CRC Press, 1995.145Moreno-Vargas, et al., "Synthesis and gylcosidase inhibitory activities of 5-(1′,4′-dideoxy-1′,4′-imino-D-erythrosyl)-2-methyl-3-furoic acid (=5-[(3S,4R)-3,4-dihydroxypyrrolidin-2-yl]-2methylfuran-3-carboxylic acid) derivatives: new leads as selective alpha-L-fucosidase and beta-galactosidase inhibitors," Helvetica Chimica Acta, vol. 86, pp. 1894-1913, 2003.146Naedele-Risha, R., et al., "Dual components of optimal asthma therapy: scientific and clinical rationale for the use of long acting beta-agonists with inhaled corticosteroids," The Journal of the American Osteopathic Association, vol. 101, No. 9, Sep. 2001, pp. 526-533.147Nathan, et al., "A once daily fluticasone proprionate aqueous nasal spray is an effective treatment for seasonal allergic rhinitis," Annals of Allergy, 1991, vol. 67, pp. 332-338.148Nelson, Harold, S., et al., Fluticasone propionate-salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast, J. Allergy Clin. Immunol., vol. 106, No. 6, Dec. 2000, pp. 1088-1095.149Nielsen, et al., "Intranasal corticosteroids for allergic rhinitis: superior relief?" Drugs, 2001, vol. 61, No. 11, pp. 1535-1691.150Nielsen, Lars P., "Comparison of Intranasal Corticosteroids and Antihistamines in Allergic Rhinitis, A Review of Randomized, Controlled Trials," Am. J. Respir Med. 2003, vol. 2, No. 1, Cover page, publishing page, pp. 55-65., ADIS International Limited.151Nielsen, Lars Peter, et al., "Intranasal Corticosteroids for Allergic Rhinitis, Superior Relief?," Drugs 2001, vol. 61, No. 11, pp. 1563-1579, ADIS International Ltd.152Notice of Non-responsive Amendment dated Jul. 6, 2011 (3 pages), U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.153Notice of Opposition to the grant of patent on Patent Application No. 762/2001 (140397) (Pakistan), 2010.154Observations on patentability of the object of the patent application PV 2003-352 (Czech Republic), 2003.155O'Conner, B. J., "Combination therapy," Pulmonary Pharmacology and Therapeutics, vol. 11, No. 5/6, 1998, pp. 397-399.156Office Action (Final) dated Feb. 18, 2011 (23 pages), U.S. Appl. No. 12/508,388, filed Jul. 23, 2009.157Office Action (Final) dated Feb. 24, 2011 (20 pages), U.S. Appl. No. 12/508,393, filed Jul. 23, 2009.158Office Action (Final) dated May 3, 2011 (8 pages), U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.159Office Action dated Apr. 7, 2011 (3 pages) from counterpart application, AU2009243420.160Office Action dated Aug. 31, 2010 (6 pages), U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.161Office Action dated Jul. 11, 2011-20632 IL.162Office Action dated Jul. 11, 2011�20632 IL.163Office Action dated Mar. 29, 2011 (3 pages) from counterpart application, AU2009243422.164Office Action dated Nov. 30, 2010 (16 pages), U.S. Appl. No. 12/374,523 filed on Jan. 21, 2009.165Office Action dated Sep. 15, 2011 of U.S. Appl. No. 12/508,393 filed Jul. 23, 2009.166Office Action dated Sep. 30, 2010, U.S. Appl. No. 12/508,388, filed Jul. 23, 2009, 22 pages.167Office Action dated Sep. 30, 2010, U.S. Appl. No. 12/508,393, filed Jul. 23, 2009, 31 pages.168Office Action dated Sep. 9, 2011 of U.S. Appl. No. 12/508,388 filed Jul. 23, 2009.169Ong, John T. H., et al., "Intrinsic potencies of novel thiol ester corticosteroids RS-85095 and RS-21314 as compared with clobetasol 17-propionate and fluocinonide," Arch Dermatol, vol. 125, Dec. 1989, pp. 1662-1665.170Ong, John T. H., et al., "Micellar solubilization of timobesone acetate in aqueous and aqueous propylene glycol solutions of nonionic surfactants," Pharmaceutical Research, vol. 5, No. 11, 1988, pp. 704-708.171Onrust, et al., "Mometasone furoate, a review of its intranasal use in allergic rhinitis," Drugs, vol. 56, No. 4, Oct. 1998, pp. 725-745, vol. 21.172Opponent's R116 Submission for EP1519731, 2011.173Opponent's Statement of Opposition for EP1519731, 2011.174Opponent's submission dated Oct. 6, 2011 to EP Patent No. 1519731.175Opponent's submission dated Sep. 23, 2011 regarding additional documents on EP Patent No. 1519731.176Opponent's submission dated Sep. 23, 2011 regarding list of attendees at oral proceedings on EP Patent No. 1519731.177Opposition to EP 1518731, Aug. 8, 2011, 19 pages.178Patent application entitled "Combination of azelastine and steroids," by Amar Lulla, et al., filed Sep. 10, 2010 as U.S. Appl. No. 12/879,515.179Patentee's response of Sep. 6, 2010 of EP Patent No. 1519731.180Patentee's submission dated Oct. 5, 2011 to EP Patent No. 1519731.181Patentee's submission dated Sep. 19, 2011 on EP Patent No. 1519731.182Patentee's submission dated Sep. 29, 2011 regarding list of attendees at oral proceedings on EP Patent No. 1519731.183PCT/GB01/03495, International Preliminary Examination Report, date of mailing: Aug. 30, 2002.184Pettersson, Bertil, et al., "Re-evaluation of the classical mycoplasma lipophilum cluster (Weisburg, et al., 1989) and description of two new clusters in the hominis group based on 16S rDNA sequences," Int'l Journal of Systematic & Evolutionary Microbiology, 2001, vol. 51, pp. 633-643.185Phillips, G. H., et al., "Synthesis and structure activity relationships in a series of anti-inflammatory corticosteroid analogues, halomethyl androstane�17B-carbothioates and�17B-carboselenoates," Journal of Medicinal Chemistry, 1994, vol. 37, pp. 3717-3729.186Popper, T. L., et al., "Structure-activity relationship of a series of novel topical corticosteroids," Journal of Steroid Biochemistry, 1987, vol. 27, pp. 837-843.187Pre-Grant Opposition, Indian Patent Application 2092/KOLNP/2007 dated Jun. 8, 2007, 183 pages.188Prescribing Information for Asteproe�, Nov. 2010, 20 pages, Meda Pharmaceuticals Inc., Somerset, NJ, US.189Prescribing Information for Rhinocort Aqua(TM), Dec. 2010, 32 pages, AstraZeneca LP, Wilmington, DE, US.190Prescribing Information for Rhinocort Aqua�, Dec. 2010, 32 pages, AstraZeneca LP, Wilmington, DE, US.191 *preservative. (n.d.) Dorland's Medical Dictionary for Health Consumers. (2007). Retrieved Nov. 4, 2009 from http://medical-dictionary.thefreedictionary.com/preservative.192 *preservative. (n.d.) Mosby's Medical Dictionary, 8th edition. (2009). Retrieved Nov. 4, 2009 from http://medical-dictionary.thefreedictionary.com/preservative.193 *preservative. (n.d.) The American Heritage� Medical Dictionary. (2007). Retrieved Nov. 4, 2009 from http://medical-dictionary.thefreedictionary.com/preservative.194Product Information Flonase (Fluticasone proprionate) Nasal Spray 50 mcg, 2004, pp. 1-13.195Product Information Rhinocort Aqua (budesonide) Nasal Spray 32 mcg, 2005, pp. 1-2.196Product Information, Nasonex�, Aug. 2001, 22 pages, Schering Corporation, Kenilworth, NJ, US.197Product Specification Bulletin, Avicel� CL-611, Bulletin AVC611-SPEC-02/09.RS, 2 pages, FMC BioPolymer, Feb. 2009.198Product Specification Bulletin, Avicel� RC-591, Bulletin AVC591-SPEC-02/09.RS, 2 pages, FMC BioPolymer, Feb. 2009.199Rapid response report: summary with critical appraisal, fluticasone furoate versus fluticasone propionate for seasonal allergic rhinitis: a review of the clinical and cost-effectiveness, Jun. 13, 2011, Fluticasone Furoate for Seasonal Allergic Rhinitis.200Ratner, Paul H., et al., "A Comparison of the Efficacy of Fluticasone Propionate Aqueous Nasal Spray and Loratadine, Alone and in Combination, for the Treatment of Seasonal Allergic Rhinitis," The Journal of Family Practice, Aug. 1998, vol. 47, No. 2, pp. 118-125, Appleton & Lange.201Ratner, Paul H., et al., "Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis," Annals of Allergy, Asthma & Immunology, Jan. 2008, vol. 100, Cover page, publishing page, pp. 74-81.202Reddy, Indra K., ed., Ocular Therapeutics and Drug Delivery: A Multi-Disciplinary Approach, 1996, pp. 382-385 plus cover page and publication page, Technomic Publishing Company, Inc.203Result of oral proceedings dated Oct. 12, 2011 of EP Patent No. 1519731.204Safety Data Sheet, SDS No. 110536, Jun. 23, 2008, V13, Beconase Hayfever Allergy Spray, 5 pages, GlaxoSmithKline.205Safety Data Sheet, SDS No. 110556, Jul. 4, 2008, V14, Flonase Nasal Spray, 5 pages, GlaxoSmithKline.206Sakagami, et al., "Mucoadhexive BDP microspheres for powder inhalation�their unique pharmacokinetic-pharmacodynamic profiles," Respiratory Drug Delivery, vol. VI, pp. 193-199, 1998.207Salib Rami Jean, et al., "Safety and Tolerability Profiles of Intranasal Antihistamines and Intranasal Corticosteroids in the Treatment of Allergic Rhinitis," Drug Safety 2003, vol. 26, No. 12, Cover page, publication page, pp. 863-893, ADIS Data Information BV.208Salib, et al.; "Safety and Tolerability Profiles of Intranasal Anihistaminese and Intranasal Corticosteroids in the Treatment of Allergic Rhinitis;" Drug Safety; 2003; vol. 26, No. 12, pp. 829-911.209Sandham, et al., "Synthesis and biological properties of novel glucocorticoid androstene C-17 furoate esters," Bioorganic & Medicinal Chemistry, 2004, vol. 12, pp. 5213-5224.210Scadding, et al., "Clinical and physiological effects of fluticasone propionate aqueous nasal spray in the treatment of perennial rhinitis," Rhinology, 1991, Suppl. 11, pp. 37-43.211Search Report dated May 12, 2009 of EP 09075100.212Search Report dated May 12, 2009 of EP 09075101.213Settipane, et al., "Triamcinolone acetonide aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study," Clin. Ther., 1995, vol. 17, No. 2, pp. 252-263.214Shapiro, et al., "17 heteroaroyl esters of corticosteroids 2. 11 beta hydroxy series," Journal of Medicinal Chemistry, American Chemical Society, Washington, US, vol. 30, No. 9, 1987, pp. 1581-1588.215Shapiro, et al., "17-esters and 17,21-diesters of 9-alpha, 11-beta-dichlorocorticoids. Synthesis and anti-inflammatory activity," Steroids, vol. 9, No. 2, pp. 143-156, 1967.216Shapiro, et al., "Synthesis and structure-activity studies of corticosteroid 17-heterocyclic aromatic esters. 1. 9-alpha, 11-beta dichloro series," Journal of Medicinal Chemistry, vol. 30, No. 6, pp. 1068-1073, 1987.217Shenfield, "Fixed drug combinations: which ones can be recommended?" Current Therapeutics, 1986, pp. 15-29.218Simpson, Richard J., "Budesonide and terfenadine, separately and in combination, in the treatment of hay fever," Annals of Allergy, Dec. 1994, vol. 73, Cover page, publication page, pp. 497-502.219Smith, et al., "In vitro glucocorticoid receptor binding and transcriptional activiation by topically active glucocorticoids," Arzneimettelforschung, 1998, 48(II)(9), pp. 956-959.220Smith, N., et al., "Comparison of the electroosmotic flow profiles and selectivity of stationary phases used in capillary electrochromatography," Journal of Chromatography A., vol. 832, 1999, pp. 41-54.221Souness, et al., "Immunosuppressive and anti-inflammatory effects of cyclic AMP phosphodiesterase (PDE) type 4 inhibitors," Immunopharmacology, 2000, vol. 47, Nos. 2/3, pp. 127-162.222Spector, Sheldon, "Ideal pharmacotherapy for allergic rhinitis," J Allergy Clin Immunol, vol. 103, No. 3, Part 2, pp. S386-S387, 1999.223Stempel, et al., "Treatment of allergic rhinitis: an evidence-based evaluation of nasal corticosteroids versus nonsedating antihistamines," Am. J. Man. Care, 1998, vol. 4, pp. 89-96.224Study No. 03DMW062�"Pharmacokinetics of GW685698X and CC118781 (fluticasone propionate) when co-administered by the intratracheal or intravenous route to the anaesthetised white pig," 2004.225Study No. B30947�"The Pharmacokinetics of GW685698X and CC118781 following intratracheal co-administration to the anaesthetised white pig," 2003.226Szefler, Stanley J., et al., Chapter 21, "Glucocorticoids in severe asthma: mechanisms of action and route of administration," Difficult Asthma, pp. 371-375, Martin Dunitz Ltd., Informa Health Care, 1999.227Tanaka, et al., "Synthesis of 4H-furo[3,2-b]indole derivatives. III (1). Preparation of 4H-furo[3,2-b]indole-2-carboxylic acid derivatives," Journal Heterocyclic Chemistry, vol. 16, pp. 785-788, 1979.228The United States Pharmacopoeia, 23rd Ed., US Pharmacopoeia Convention, Inc., Rockville MD, 1995, pp. 1843-1844, "Physical Tests/(941) X-Ray Diffraction."229Togashi, et al., 9-fluoro-11B, 17, 21-trihyrdroxy-16a-methyl-1,4-pregnadiene-3, 20-dione 21- cyclohexanecarboxylate 17-cyclopropanecarboxylate (ST126); Oyo Yakuri, 2002, vol. 63, No. 5/6, pp. 61-77.230Ueno, et al., "Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17. Alpha-esters containing a functional group," Journal of Medicinal Chemistry, American Chemica Society, vol. 34, No. 8, Aug. 1991, pp. 2468-2473.231Undem, et al., "Neural integration and allergic disease," J. Allergy Clin. Immunol., 2000, vol. 106, No. 5, pp. S213-S220.232Van As, et al., "Once daily flluticasone propionate is as effective for perennial allergic rhinitis as twice daily beclomethasone dipropionate," J. Allergy Clin. Immunol., 1993, vol. 91, No. 6, pp. 1146-1154.233Van Bavel, et al., "Ocular efficacy and clinician overall evaluation of intranasal fluticasone proprionate (FP) versus loratadine (LOR) in seasonal allergic rhinitis (SAR)," Annals of Allergy, Asthma, & Immunology, 1997, vol. 78, p. 128, Abstract P101.234Van Der Molen, et al., "Effects of the long acting beta agonist formoterol on asthma control in asthmatic patients using inhaled corticosteroids," Thorax, vol. 52, No. 6, 1997, pp. 535-539.235Vanrell, "Preservatives in ophthalmic formulations: an overview," Arch. Soc. Esp. Oftalmol., 2007, vol. 82, pp. 531-532.236Veramyst (fluticasone furoate) Nasal Spray, GlaxoSmithKline, 2007, Summary Sheet, pp. 1-20.237Wang, De-Yun, "Treatment of Allergic Rhinitis: H1-Antihistamines and Intranasal Steroids," Current Drug Targets-Inflammation & Allergy, 2002, vol. I, pp. 215-220, Bentham Science Publishers Ltd.238Wang, De-Yun, "Treatment of Allergic Rhinitis: H1-Antihistamines and Intranasal Steroids," Current Drug Targets�Inflammation & Allergy, 2002, vol. I, pp. 215-220, Bentham Science Publishers Ltd.239Wenkert, et al., "Short syntheses of furan and catechol derivatives. A synthesis of hydrourushiol1,2," Journal American Chemical Society, vol. 105, pp. 2021-2029, 1983.240Westlund, et al., "Fluticasone propionate aqueous nasal spray 200 mg once daily provides relief of ocular symptoms associated with seasonal allergic rhinitis," 57th Annual Meeting of the American Academy of Allergy, Asthma and Immunology, New Orleans LA, Mar. 16-21, 2001, Abstract No. 522.241Wiseman, Lynda R., et al., "Intranasal Fluticasone Propionate: A Reappraisal of its Pharmacology and Clinical Efficacy in the Treatment of Rhinitis," Drugs, 1997, vol. 53, No. 5, pp. 885-907, Adis International Limited.242Woodford, et al., "Activity and bioavailability of a new steroid (Timobesone acetate) in cream and ointment compared with Lidex and Dermovate creams and ointments and Betnovate cream," Int'l Journal of Pharmaceutics, 1985, vol. 26, pp. 145-155.243World Review 2001: The Pharmaceutical Market, vol. 1 International, Ims Health, 2001, cover, preface, and copyright pages plus pp. 4-42 and 5-1 through 5-11, IMS A.G.* Cited by examinerReferenced byCiting PatentFiling datePublication dateApplicantTitleUS8859531Nov 18, 2011Oct 14, 2014Hanlim Pharmaceutical Co., LtdPharmaceutical composition including mometasone furoate and azelastine hydrochloride for nasal administrationUS8937057Oct 3, 2012Jan 20, 2015Cipla LimitedCombination of azelastine and mometasone for nasal administrationClassifications U.S. Classification514/171International ClassificationA61K31/56, A61K9/00, A01N45/00, A61K31/58, A61K31/57, A61P37/08, A61P11/06, A61P27/14, A61K31/573, A61K31/55, A61P11/00Cooperative ClassificationA61K31/573, A61K31/58, A61K31/55European ClassificationA61K31/58, A61K31/573, A61K31/55Legal EventsDateCodeEventDescriptionNov 18, 2014CCCertificate of correctionJul 6, 2005ASAssignmentOwner name: CIPLA LIMITED, INDIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LULLA, AMAR;MALHOTRA, GEENA;REEL/FRAME:016833/0985Effective date: 20050523RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services