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# FDA Updates Off-Patent, Off-Exclusivity List
- URL: https://www.fdaweb.com/fda-updates-off-patent-off-exclusivity-list-2/
- Published: 2021-12-16T12:00:00.000Z
- Updated: 2026-09-14T17:26:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150788

FDA has updated the “List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic” to include 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. Starting with this [update](https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/list-patent-exclusivity-drugs-without-approved-generic?utm%5Fmedium=email&utm%5Fsource=govdelivery), FDA says it will publish 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 agency says it maintains the list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition. The list is updated every six months.