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# New Guide on Drug 3-Year Exclusivity
- URL: https://www.fdaweb.com/new-guide-on-drug-3-year-exclusivity/
- Published: 2026-03-03T12:00:00.000Z
- Updated: 2026-09-14T13:34:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160749

FDA has posted a new draft guidance entitled [“New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.”](https://links-2.govdelivery.com/CL0/https:%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fnew-clinical-investigation-exclusivity-3-year-exclusivity-drug-products-questions-and-answers%3Futm%5Fmedium=email%26utm%5Fsource=govdelivery/1/0101019cb4a89d32-74b8a835-a7ff-4011-8455-9775f64642ef-000000/1YZOcbmT6mXEmzUE3Q5XUsLQkoFvFSnL2APevtcaBdU=446?ref=fdaweb.com) The document is intended to assist applicants requesting new clinical investigation exclusivity (“3-year exclusivity”) for a new drug application (NDA) or NDA supplement and provides other information about 3-year exclusivity. The guidance:

- discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and
- clarifies the processes for:
  - applicants to request 3-year exclusivity,
  - FDA to make 3-year exclusivity eligibility determinations, and
  - FDA providing notice of those determinations in Approved Drug Products with Therapeutic Equivalence Evaluations (the “[Orange Book](https://links-2.govdelivery.com/CL0/http:%2F%2Fwww.fda.gov%2Forangebook%3Futm%5Fmedium=email%26utm%5Fsource=govdelivery/1/0101019cb4a89d32-74b8a835-a7ff-4011-8455-9775f64642ef-000000/vTlWv-v95Q4gTH8Gde10AScpeS9JQIww2Cc3gtdtbyE=446?ref=fdaweb.com)”).

FDA intends to update the document to include additional answers to commonly asked questions, as appropriate.