> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Off-Patent, Off-Exclusivity List Updated
- URL: https://www.fdaweb.com/off-patent-off-exclusivity-list-updated/
- Published: 2020-06-18T12:00:00.000Z
- Updated: 2026-09-14T16:18:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147038

FDA says it has published an update to the “List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic.” A [statement](http://s2027422842.t.en25.com/e/es?s=2027422842&e=343803&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=a8d76d24426448dea4049d8be7500912&elqaid=13011&elqat=1&ref=fdaweb.com) says the list includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update, and for which FDA has not approved an ANDA referencing that NDA product.

“FDA maintains this list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition,” the notice says. “We update this list every six months to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients.”