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# FDA Updates Off-Patent, Off-Exclusivity List
- URL: https://www.fdaweb.com/fda-updates-off-patent-off-exclusivity-list/
- Published: 2020-12-17T12:00:00.000Z
- Updated: 2026-09-14T16:40:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148324

FDA has posted an updated List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic. The agency says the [list](https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/list-patent-exclusivity-drugs-without-approved-generic?utm%5Fmedium=email&utm%5Fsource=govdelivery) includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update and for which the agency has not approved an ANDA referencing the NDA product.

The list is maintained, FDA says, to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition. It is updated every six months.