New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers March 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-clinical-investigation-exclusivity-3-year-exclusivity-drug-products-questions-and-answers?utm_medium=email&utm_source=govdelivery Today, FDA published the new draft guidance for industry, “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This guidance 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. This 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”). FDA intends to update this draft guidance document to include additional answers to commonly asked questions, as appropriate. The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch-Waxman Amendments) reflects Congress’s efforts to balance the need to “make available more low-cost generic drugs by establishing a generic drug approval procedure” with new incentives for drug development in the form of exclusivities and patent term extensions. These efforts include a 3-year period of exclusivity for drugs approved in certain NDAs or supplements to NDAs during which certain NDAs and abbreviated new drug applications (ANDAs) may not be approved for exclusivity-protected conditions of approval of such drugs. An application may qualify for 3-year exclusivity if it is an NDA or NDA supplement: for a drug that includes an active moiety that has been approved in another 505(b) application (or, for a fixed-combination drug product where each of the active moieties were previously approved in another 505(b) application); and that contains reports of new clinical investigations that are: not bioavailability studies; essential to the approval of the application (or supplement); and conducted or sponsored by the applicant. FDA issued this guidance as part of our Drug Competition Action Plan, which seeks to improve the efficiency of the generic drug development, review, and approval process. An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines.