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                FDA Basics for Industry

FDA Basics for Industry

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          FDA Basics for Industry
          How can I better understand Patents and Exclusivity?FDA Basics for Industry How can I better understand Patents and Exclusivity?
  
  	
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    PrintPatents are granted by the United States Patent and Trademark Office (USPTO) anywhere along the development lifeline of a drug and can encompass a wide range of claims. Drugs may be issued multiple patents. FDA is required by law to list in the Orange Book the patent number and expiration date of each patent that claims the drug or method of using the drug. FDA defines drug as drug substance (active ingredient) or drug product (formulation and composition).Search USPTO’s database for information about individual patents, and also find more information on patentsExclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but need not do so. Exclusivity is granted to a new drug applicant if statutory requirements are met. See 21 Code of Federal Regulations (C.F.R.) 314.108. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.The length of exclusivity depends on the type of exclusivity granted:Orphan Drug (ODE) - 7 yearsNew Chemical (NCE)- 5 years"Other" Exclusivity - 3 years for a "change" if criteria are metPediatric Exclusivity (PED) - 6 months added to existing Patents/ExclusivityPatent Challenge – (PC) – 180 days (this exclusivity is for Abbreviated New Drug Applications (ANDAs only)Relevant Resources:Frequently Asked Questions (FAQs) on Patents and Exclusivity[!--$include fdagov_ratings_form--]

                                                                                  Content current as of:
      02/01/2016FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
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