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# FDA Updates Off-Patent, Off-Exclusivity List
- URL: https://www.fdaweb.com/fda-updates-off-patent-off-exclusivity-list-3/
- Published: 2022-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:49:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152090

FDA has updated its list of off-patent, off-exclusivity drugs without an approved generic. 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), which is updated every six months, includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of each update and for which the agency has not approved an ANDA referencing the NDA.

The agency says that as part of the latest update it has refined the processes for generating the list so it captures additional drug products approved under an NDA for which no ANDA has been approved. As a result, it says, several new entries have been added to the list.