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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Abbreviated New Drug Application (ANDA)
  7. List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
  1. Abbreviated New Drug Application (ANDA)

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The FDA updates this list every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition.

Starting in December 2021, FDA publishes two versions of the list, one for prescription drug products and one for over-the-counter drug products that are approved and marketed under an NDA.

The prescription and over-the-counter lists are both separated into three sections:

  • Part I identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.
  • Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.
  • The Appendix identifies NDA drug products that were removed from Part I or Part II of the list because one or more ANDAs referencing such NDA drug products have been approved since the previous list publication.

Please refer to the PDF versions of the lists for full details and methodology.

Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

  • December 2023 Lists of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
    • Prescription (Rx) Drug Products PDF | Excel
    • Over-the-Counter (OTC) Drug Products PDF | Excel

Previous Lists of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

  • June 2023 Lists of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
    • Prescription (Rx) Drug Products PDF | Excel
    • Over-the-Counter (OTC) Drug Products PDF | Excel
  • December 2022 Lists of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
    • Prescription (Rx) Drug Products PDF | Excel
    • Over-the-Counter (OTC) Drug Products PDF | Excel
  • June 2022 Lists of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
    • Prescription (Rx) Drug Products PDF | Excel
    • Over-the-Counter (OTC) Drug Products PDF | Excel
  • December 2021 Lists of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
  • June 2021  List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic PDF | Excel
  • December 2020 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic PDF | Excel
  • June 2020 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic PDF | Excel
  • December 2019 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic  PDFExcel
  • June 2019 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic  PDFExcel
  • December 2018 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic  PDFExcel
  • June 2018 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic  PDFExcel
  • December 2017 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic  PDFExcel
  • June 2017 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic  PDFExcel
 
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