Source: http://www.google.com/patents/US8158154?dq=7,346,545
Timestamp: 2016-07-24 09:13:33
Document Index: 130405892

Matched Legal Cases: ['Application No. 2', 'Application No. 2006', 'Application No. 2006', 'Application No. 2006', 'Application No. 2006', 'Application No. 2005']

Patent US8158154 - Nasal pharmaceutical formulations and methods of using the same - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsNasal pharmaceutical formulations comprising a drug substance having a specific particle size distribution profile are disclosed herein. Such profile provides increased bioavailability, increased efficacy or prolonged therapeutic effect of the drug substance when administered intranasally. The formulations...http://www.google.com/patents/US8158154?utm_source=gb-gplus-sharePatent US8158154 - Nasal pharmaceutical formulations and methods of using the sameAdvanced Patent SearchPublication numberUS8158154 B2Publication typeGrantApplication numberUS 11/931,424Publication dateApr 17, 2012Filing dateOct 31, 2007Priority dateApr 16, 2003Fee statusPaidAlso published asCA2522291A1, CA2522291C, CN1805729A, CN1805729B, EP1613281A1, US7811606, US7972627, US20040208831, US20060039871, US20080058295, WO2004091575A1Publication number11931424, 931424, US 8158154 B2, US 8158154B2, US-B2-8158154, US8158154 B2, US8158154B2InventorsImtiaz ChaudryOriginal AssigneeDey Pharma, L.P.Export CitationBiBTeX, EndNote, RefManPatent Citations (73), Non-Patent Citations (36), Referenced by (7), Classifications (19), Legal Events (8) External Links: USPTO, USPTO Assignment, EspacenetNasal pharmaceutical formulations and methods of using the same
At least a 2-yr history of moderate-to-severe SAR due to fall pollen; Individuals 12 years of age and older; Confirmed IgE-mediated hypersensitivity to local fall pollen within last 12 months (a positive result is required); Minimum TNSS of 8 of a maximum of 12 on at least 3 days during the baseline period, one of which must have been within 3 days of Day 1; If receiving immunotherapy, a stable maintenance regimen for 30 days prior to study enrollment; General good health and free of disease or concomitant treatment that could interfere with interpretation of study results; Written informed consent/pediatric assent; and, Willingness to comply with study procedures. Patients who met all criteria were then randomized to 1 of 5 treatment groups: (1) Dey BD Nasal Spray (0.042%) Low Dose—1 spray of Bottle 1 (Dey BD) in each nostril followed by 1 spray of Bottle 2 (placebo) in each nostril twice daily (morning and evening); (2) Dey BD Nasal Spray (0.042%) High Dose—1 spray of Bottle 1 (Dey BD) in each nostril followed by 1 spray of Bottle 2 (Dey BD) in each nostril twice daily (morning and evening); (3) Beconase AQ� Low Dose—1 spray of Bottle 1 (Beconase AQ�) in each nostril followed by 1 spray of Bottle 2 (placebo) in each nostril twice daily (morning and evening); (4) Beconase AQ� High Dose—1 spray of Bottle 1 (Beconase AQ�) in each nostril followed by 1 spray of Bottle 2 (Beconase AQ�) twice daily (morning and evening); and (5) placebo—1 spray of Bottle 1 (placebo) in each nostril followed by 1 spray of Bottle 2 (placebo) in each nostril twice daily (morning and evening).
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS3091569Aug 26, 1960May 28, 1963Mead Johnson & CoMucolytic-nu-acylated sulfhydryl compositions and process for treating animal mucusUS5174475Mar 26, 1991Dec 29, 1992Glaxo Inc.Sequential dosing of antifungal and antiinflammatory compositionsUS5593688Jun 6, 1995Jan 14, 1997Nexstar Pharmaceuticals, Inc.Liposomal targeting of ischemic tissueUS5858330Mar 18, 1996Jan 12, 1999Dompe' S.P.A.Pharmaceutical formulations in form of thixotropic gelUS5976573Jul 3, 1996Nov 2, 1999Rorer Pharmaceutical Products Inc.Aqueous-based pharmaceutical compositionUS5993781May 19, 1995Nov 30, 1999Glaxo Wellcome Australia Ltd.Fluticasone propionate nebulizable formulationsUS6113894Sep 3, 1998Sep 5, 2000Smith; S. GregoryOphthalmic compositions and process of usingUS6207703Oct 22, 1998Mar 27, 2001Jens PonikauMethods and materials for treating and preventing inflammation of mucosal tissueUS6241969Jun 26, 1998Jun 5, 2001Elan Corporation PlcAqueous compositions containing corticosteroids for nasal and pulmonary deliveryUS6291500Oct 22, 1998Sep 18, 2001Jens PonikauMethods and materials for treating and preventing inflammation of mucosal tissueUS6368616Jan 14, 1998Apr 9, 2002Senju Pharmaceutical Co., Ltd.Aqueous suspension for nasal administration of loteprednolUS6410062Jun 2, 2000Jun 25, 2002Johnson & Johnson Consumer France Sas I3540Method for the topical treatment and prevention of inflammatory disorders and related conditions using extracts of feverfew (Tanacetum parthenium)US6464958Oct 28, 1999Oct 15, 2002Chiesi Farmaceutici S.P.A.Process for the preparation of suspensions of drug particles for inhalation deliveryUS6465709Jul 7, 2000Oct 15, 2002Johnson & Johnson Consumer Companies, Inc.Exothermic bandageUS6509028Jun 17, 2002Jan 21, 2003Epicept CorporationMethods and compositions for treating pain of the mucous membraneUS6555566May 25, 2001Apr 29, 2003Mayo Foundation For Medical Education And ResearchMethods and materials for treating and preventing inflammation of mucosal tissueUS6608054Mar 18, 2002Aug 19, 2003Boehringer Ingelheim Pharma KgPharmaceutical compositions based on anticholinergics and endothelin antagonistsUS7811606 *Apr 16, 2003Oct 12, 2010Dey, L.P.Nasal pharmaceutical formulations and methods of using the sameUS20010002404Dec 5, 2000May 31, 2001Webb Nigel L.Fatty acid-pharmaceutical agent conjugatesUS20020006944Mar 7, 2001Jan 17, 2002Shigenori OhkawaTricyclic compounds, their production and useUS20020010208May 1, 2001Jan 24, 2002Victor ShashouaDha-pharmaceutical agent conjugates of taxanesUS20020013331Jun 25, 2001Jan 31, 2002Williams Robert O.Methods and compositions for treating pain of the mucous membraneUS20020052390Oct 22, 1998May 2, 2002Jens PonikauMethods and materials for treating and preventing inflammation of mucosal tissueUS20020061281Aug 31, 2001May 23, 2002Osbakken Robert S.Aerosolized anti-infectives, anti-inflammatories, and decongestants for the treatment of sinusitisUS20020071874Jul 10, 2001Jun 13, 2002Allergan Sales, Inc.Compositions containing therapeutically active components having enhanced solubilityUS20020124820Dec 7, 2001Sep 12, 2002Meta-Motoren-Und Energie-Technik GmbhApparatus for switching the operation of a change valve of a combustion engineUS20020136918May 8, 2002Sep 26, 2002Calsonic Kansei CorporationFormed strip and roll formingUS20020177609Mar 25, 2002Nov 28, 2002Swindell Charles S.Fatty alcohol drug conjugatesUS20020192288Jun 17, 2002Dec 19, 2002Williams Robert O.Methods and compositions for treating pain of the mucous membraneUS20020198209May 3, 2001Dec 26, 2002Allergan Sales Inc.Compositions having enhanced pharmacokinetic characteristicsUS20030017199May 1, 2002Jan 23, 2003Woodward David F.Compositions having enhanced pharmacokinetic characteristicsUS20030065023Mar 25, 2002Apr 3, 2003Swindell Charles S.Fatty amine drug conjugatesUS20040045805Jun 29, 2001Mar 11, 2004Lancaster Robert WilliamNovel process for preparing and harvesting crystalline particlesUS20040081626Dec 28, 2000Apr 29, 2004Wiwik WatanabeInhalation particlesUS20040136918Mar 4, 2002Jul 15, 2004Garrett Ronique NichelePharmaceutical formulationsUS20040141925Oct 31, 2003Jul 22, 2004Elan Pharma International Ltd.Novel triamcinolone compositionsUS20070140980Dec 17, 2003Jun 21, 2007Chiesi Farmaceutici S.P.A.Preparation of sterile aqueous suspensions comprising micronised crystalline active ingredients for inhalationUS20080050442Oct 31, 2007Feb 28, 2008Dey, L.P.Nasal pharmaceutical formulations and methods of using the sameEP0343268A1May 25, 1988Nov 29, 1989Biogal GyogyszergyarPharmaceutical composition and process for preparing the sameEP0385445A2Feb 28, 1990Sep 5, 1990Isamu HorikoshiMethod of forming a suspension and composition formed by said methodJP2000508675A Title not availableJP2001002589A Title not availableJP2001520188A Title not availableJP2001523638A Title not availableJP2002539154A Title not availableJP2003506396A Title not availableJP2005503378A Title not availableJP2005506369A Title not availableJPH0753358A Title not availableJPH01100120A Title not availableJPH03165833A Title not availableJPH05506642A Title not availableJPH11130659A Title not availableJPH11514979A Title not availableWO1986003750A1Dec 16, 1985Jul 3, 1986Riker Laboratories, Inc.Physically modified beclomethasone dipropionate suitable for use in aerosolsWO1992004365A1Sep 6, 1991Mar 19, 1992Schering CorporationMometasone furoate monohydrate, process for making same and pharmaceutical compositionsWO1992017183A1Mar 9, 1992Oct 15, 1992Glaxo Inc.Sequential dosing of antifungal and antiinflammatory compositionsWO1997008950A1Sep 9, 1996Mar 13, 1997Fuisz Technologies, Ltd.System for rendering substantially non-dissoluble bio-affecting agents bio-availableWO1999018971A1Oct 6, 1998Apr 22, 1999Schering CorporationMometasone furoate suspensions for nebulizationWO2000012063A1Aug 24, 1999Mar 9, 2000Teijin LimitedPowdery pernasal compositionsWO2000025746A2Oct 28, 1999May 11, 2000Chiesi Farmaceutici S.P.A.A process for the preparation of suspensions of drug particles for inhalation deliveryWO2000027363A1Nov 12, 1999May 18, 2000Elan Pharma International Ltd.Aerosols comprising nanoparticle drugsWO2001010409A1Aug 3, 2000Feb 15, 2001Glaxo Wellcome Kabushiki KaishaAqueous nasal formulationWO2001013885A1Aug 21, 2000Mar 1, 2001Norton Healthcare Ltd.Method to produce powders for pulmonary or nasal administrationWO2001032125A2Nov 3, 2000May 10, 2001Glaxo Group LimitedApparatus and process for preparing crystalline particlesWO2001049263A1Dec 28, 2000Jul 12, 2001Orion CorporationInhalation particlesWO2001078743A1Apr 11, 2001Oct 25, 2001Glaxo Group LimitedMedical combinations comprising tiotropium and mometasoneWO2002000199A1Jun 29, 2001Jan 3, 2002Glaxo Group LimitedNovel process for preparing and harvesting crystalline particlesWO2002055136A2Nov 30, 2001Jul 18, 2002Nephros Therapeutics IncIntrasvascular drug delivery device and use thereforWO2002072066A1Feb 5, 2002Sep 19, 2002Pharmacia & Upjohn CompanyComposition for rectal delivery of an oxazolidinone antibacterial drugWO2003013434A2Aug 6, 2002Feb 20, 2003Genomed, LlcMethods and compositions for treating diseases associated with excesses in aceWO2003020219A2Aug 28, 2002Mar 13, 2003Sinuspharma IncAerosolized decongestants for the treatment of sinusitisWO2003035062A1Oct 9, 2002May 1, 2003Sanofi-SynthelaboUse of irbesartan for the preparation of medicaments that are used to prevent or treat pulmonary hypertension* Cited by examinerNon-Patent CitationsReference1"Beconase AQ�" from the online Physician's Desk Reference (PDR�)-accessed Nov. 19, 2007.2"Beconase AQ�" from the online Physician's Desk Reference (PDR�)—accessed Nov. 19, 2007.3Americas Family Physician-Jan. 1, 2001-Adult Rhinosinusitis: Diagnosis and Management-J. David Osguthorpe, M.D., Medical University of South Carolina, Charleston, South Carolina-http://www.aafp.org/afp/20010101/69.html.4Americas Family Physician—Jan. 1, 2001—Adult Rhinosinusitis: Diagnosis and Management—J. David Osguthorpe, M.D., Medical University of South Carolina, Charleston, South Carolina—http://www.aafp.org/afp/20010101/69.html.5Bernstein, I. L., Is the Use of Benzalkonium Chloride as a Preservative for Nasal Formulations a Safety Concern? A Cautionary Note Based on Compromised Mucociliary Transport, J. Allergy Clin. Immunol., 105(1), Jan. 2000, pp. 39-44.6Chervinsky, P., "Clinical Review of Once-Daily Beclomethasone Dipropionate for Seasonal Allergic Rhinitis", Clinical Therapeutics, 1996, 18(5), pp. 790-796.7Drug Information Handbook, C. Lacy et al., Lexi-Comp, Inc., Cleveland, 1993, pp. 397.8Efficacy of Sch39304 in murine cyptococcosis (Aug. 1989) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd-Retrieve&db=PubMed&List-uids-25.9Efficacy of Sch39304 in murine cyptococcosis (Aug. 1989) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd—Retrieve&db=PubMed&List—uids-25.10Flonase� from the online Physician's Desk Reference (PDR�)-accessed Dec. 1, 2007.11Flonase� from the online Physician's Desk Reference (PDR�)—accessed Dec. 1, 2007.12Hebrecht et al., "Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis", N.Eng. J. Med., 2002, 347(6), pp. 408-415.13Humuy et al., Topical Antiviral Agents for Herpes Simplex Virus Infections, Drugs Today, Aug. 21, 1998, 34(12).14Invasive Aspergillus rhinosinusitis in patients with acute leukemia (Mar.-Apr. 13, 1991) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd-Retrieve&db=PubMed&List-uids-19.15Invasive Aspergillus rhinosinusitis in patients with acute leukemia (Mar.-Apr. 13, 1991) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd—Retrieve&db=PubMed&List—uids-19.16Lacy et al., 1999-2000 Drug Information Handbook, Lexi-Comp, Inc., 1999, pp. 561-563 and 568-569.17Lacy et al., 1999-2000 Drug Information Handbook, Lexi-Comp, Inc., Aug. 21, 1999, 26-28, 225-226, 453-456, 463-464 and 721-722.18Lacy, C. et al., 1999-2000 Drug Information Handbook, Lexi-Comp, Inc., Cleveland, 1999, pp. 112-114.19Lacy, C. et al., Drug Information Handbook, Lexi-Comp, Inc., Cleveland, 1999, pp. 445-446.20Mayo Clinic, Rochester Minnesota-Mayo Clinic Receives Patent for New Treatment of Chronic Sinus Infection Apr. 30, 2003-http://www.mayclinic.org/news2003-rst/1772.html.21Mayo Clinic, Rochester Minnesota—Mayo Clinic Receives Patent for New Treatment of Chronic Sinus Infection Apr. 30, 2003—http://www.mayclinic.org/news2003-rst/1772.html.22Merriam-Webster's Collegiate Dictionary, 10th edition, Merriam-Webster Incorporated: Springfield, Massachusetts, 1993 p. 311.23NCBI-PubMed-Improved method for estimation of azole antifungal inhibitory concentrations against Candida Species, based on azole/antibiotic interactions; Odds FC, Abbot AB, Pye G., Troke PF.; Mar. 17, 2003.24NCBI—PubMed—Improved method for estimation of azole antifungal inhibitory concentrations against Candida Species, based on azole/antibiotic interactions; Odds FC, Abbot AB, Pye G., Troke PF.; Mar. 17, 2003.25Office Action dated Jul. 12, 2010, and issued in connection with corresponding Canadian Application No. 2,522,294.26Office Action for Japanese Application No. 2006-504901 dated Aug. 4, 2010.27Office Action for Japanese Application No. 2006-504902 dated Aug. 4, 2010.28Office Action for Japanese Application No. 2006-504903 dated Aug. 4, 2010.29Office Action for Japanese Application No. 2006-516000 dated Sep. 8, 2010.30Office Action mailed Aug. 6, 2010, and issued in connection with corresponding U.S. Appl. No. 10/657,550.31Parikh, A., et al.; Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray; Rhinology, 39; 2001; pp. 75-79.32Russian Office Action for Russian Application No. 2005 135 333 dated Sep. 18, 2009.33The Diagnosis and Incidence of Allergic Fungal Sinusitis-Jens U. Ponikau, MD; David A. Sherris, MD; Eugene B. Kern, MD; Henry A. Homburger, MD; Evangelos Frigas, MD; Thomas A. Gaffey, MD; and Glenn D. Robers, PhD-1999 Mayo Foundation for Medical Education and Research-May Clin. Proc, Sep. 1999, vol. 74.34The Diagnosis and Incidence of Allergic Fungal Sinusitis—Jens U. Ponikau, MD; David A. Sherris, MD; Eugene B. Kern, MD; Henry A. Homburger, MD; Evangelos Frigas, MD; Thomas A. Gaffey, MD; and Glenn D. Robers, PhD—1999 Mayo Foundation for Medical Education and Research—May Clin. Proc, Sep. 1999, vol. 74.35Vippagunta et al., Crystalline Solids, Advanced Drug Delivery Reviews, Aug. 21, 2001, 3-26, 48.36Walker, Management of Allergic Rhinitis, Nursing Times, Aug. 21, 2003, 99(23).Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8663695 *Oct 31, 2007Mar 4, 2014Mylan Specialty L.P.Formulations and methods for treating rhinosinusitisUS8912174Sep 4, 2003Dec 16, 2014Mylan Pharmaceuticals Inc.Formulations and methods for treating rhinosinusitisUS9180126Feb 8, 2012Nov 10, 2015Mylan Specialty L.P.Formulations and methods for treating rhinosinusitisUS20040208830 *Apr 16, 2003Oct 21, 2004Imtiaz ChaudryNasal pharmaceutical formulations and methods of using the sameUS20040209852 *Sep 4, 2003Oct 21, 2004Imtiaz ChaudryFormulations and methods for treating rhinosinusitisUS20080050442 *Oct 31, 2007Feb 28, 2008Dey, L.P.Nasal pharmaceutical formulations and methods of using the sameUS20080058296 *Oct 31, 2007Mar 6, 2008Imtiaz ChaudryFormulations and methods for treating rhinosinusitis* Cited by examinerClassifications U.S. Classification424/489International ClassificationA61K31/56, A61K31/57, A61K9/00, A61K9/14, A61K31/7048, A61L2/00Cooperative ClassificationA61K31/7048, A61K31/573, A61K31/56, A61K31/57, A61L2/0035, A61K9/0043European ClassificationA61L2/00P2R2, A61K31/7048, A61K31/573, A61K31/57, A61K31/56, A61K9/00M14Legal EventsDateCodeEventDescriptionJun 14, 2010ASAssignmentOwner name: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENTFree format text: SECURITY AGREEMENT;ASSIGNORS:MYLAN INC.;DEY PHARMA, L.P.;DEY, INC.;AND OTHERS;REEL/FRAME:024532/0227Effective date: 20100514Nov 18, 2011ASAssignmentOwner name: DEY PHARMA, L.P. (F/K/A DEY, L.P.), NEW JERSEYFree format text: PATENT RELEASE;ASSIGNOR:JPMORGAN CHASE BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT;REEL/FRAME:027302/0391Effective date: 20111114Owner name: MYLAN PHARMACEUTICALS, INC., WEST VIRGINIAFree format text: PATENT RELEASE;ASSIGNOR:JPMORGAN CHASE BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT;REEL/FRAME:027302/0391Effective date: 20111114Owner name: MYLAN INC., PENNSYLVANIAFree format text: PATENT RELEASE;ASSIGNOR:JPMORGAN CHASE BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT;REEL/FRAME:027302/0391Effective date: 20111114Owner name: MYLAN TECHNOLOGIES, INC., VERMONTFree format text: PATENT RELEASE;ASSIGNOR:JPMORGAN CHASE BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT;REEL/FRAME:027302/0391Effective date: 20111114Nov 21, 2011ASAssignmentOwner name: BANK OF AMERICA, N.A., AS COLLATERAL AGENT, NORTHFree format text: SECURITY AGREEMENT;ASSIGNORS:MYLAN PHARMACEUTICALS, INC.;MYLAN BERTEK PHARMACEUTICALS INC.;MYLAN TECHNOLOGIES, INC.;AND OTHERS;REEL/FRAME:027270/0799Effective date: 20111114Dec 9, 2011ASAssignmentOwner name: DEY PHARMA, L.P., NEW JERSEYFree format text: CHANGE OF NAME;ASSIGNOR:DEY, L.P.;REEL/FRAME:027360/0090Effective date: 20090910Owner name: DEY, L.P., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CHAUDRY, IMTIAZ, PHD;REEL/FRAME:027359/0915Effective date: 20040422Dec 10, 2012ASAssignmentOwner name: MYLAN PHARMACEUTICALS, INC., WEST VIRGINIAFree format text: PATENT RELEASE;ASSIGNOR:BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT;REEL/FRAME:029440/0967Effective date: 20121210Owner name: MYLAN INC., PENNSYLVANIAFree format text: PATENT RELEASE;ASSIGNOR:BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT;REEL/FRAME:029440/0967Effective date: 20121210Owner name: DEY PHARMA L.P. 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