FDA Guidance Sheds (Some) New Light on 3-Year New Clinical Investigation Exclusivity March 5, 2026 By Sara W. Koblitz & Kurt R. Karst & Sarah Wicks —

https://www.thefdalawblog.com/2026/03/fda-guidance-sheds-some-new-light-on-3-year-new-clinical-investigation-exclusivity/?utm_source=rss&utm_medium=rss&utm_campaign=fda-guidance-sheds-some-new-light-on-3-year-new-clinical-investigation-exclusivity While 3-year new clinical investigation exclusivity has never been the holy grail of exclusivities—we reserve that for 7-year orphan drug exclusivity or 5-year new chemical entity exclusivity (with the plus-5-year GAIN and plus-6-month pediatric exclusivity additions!) because of the different lengths and scopes—it plays an important role in the Hatch-Waxman regulatory scheme, encouraging the development of follow-on products and/or new conditions of use. But FDA’s interpretation and application of exclusivities can be confusing, and 3-year new clinical investigation exclusivity and its intricacies seem to raise questions for industry. For that reason, FDA issued a new draft guidance document this week, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers. The guidance, in the form of FDA’s recently-preferred Questions and Answers format, addresses the statutory and regulatory criteria for eligibility for this exclusivity, as well as the content and format of requests. As a primer, 3-year exclusivity is available under the federal Food, Drug, and Cosmetic Act where a 505(b)(1), (b)(2), and supplement seeks approval of a previously approved active moiety (or moieties in the case of a fixed-dose combination product) based on reports of new clinical investigations that are 1) not bioavailability studies, 2) essential to approval, and 3) conducted or sponsored by the applicant. The draft guidance goes through each aspect of these requirements, including the types of applications for which exclusivity is available, the types of clinical investigations are eligible, the definitions of essential to approval, and the requirements for studies to have been sponsored or conducted by the applicant. FDA’s draff guidance explores the types of applications eligible for 3-year exclusivity. Clearly, an original NDA is eligible, but questions have arisen in Citizen Petitions about supplements. While supplements are eligible, the guidance clarifies that “changes that may qualify for 3-year exclusivity . . . are typically submitted in an efficacy supplement” (emphasis added). FDA is also clear that the 3-year exclusivity is recognized only for the change associated with the supplement that is supported by the new investigations.