Key Takeaways
- The U.S. Food and Drug Administration (FDA) recently published new draft guidance to clarify the New Clinical Investigation Exclusivity, or 3-Year Exclusivity, for applicants or sponsors of a new drug application (NDA) or NDA supplement.
- The guidance is written in question-and-answer format. It clarifies what clinical investigations are eligible for the exclusivity and how applicants should request it from the FDA.
The FDA recently released a new guidance, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, which the FDA plans to update with additional Q&As as appropriate.1 As referenced in the title, the New Clinical Investigation Exclusivity is also referred to as the 3-Year Exclusivity.2
The 3-Year Exclusivity protects “new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant.”3 The draft guidance clarifies the FDA’s multifactorial approach for evaluating eligibility for the 3-Year Exclusivity, including what qualifies as a “new clinical investigation,” what constitutes “essential to approval,” what constitutes “conducted or sponsored” by applicant, such as mergers, acquisition, or licensing transactions, and the process for requesting the exclusivity. This exclusivity is available to New Drug Applications (NDAs) and NDA supplements that are not eligible for New Chemical Entity (5-year) Exclusivity.
Among other evidence, the applicant needs to show that it has “conducted or sponsored” the new clinical investigation in order to qualify for the exclusivity. To this end, applicants can provide documentation showing that it has either 1) taken over, merged with, or purchased the predecessor entity, or 2) purchased all rights to the drug asset from another entity or acquired exclusive rights to the study. The FDA notes that purchase of nonexclusive rights to a clinical investigation after it is completed is not sufficient to qualify for the 3-Year Exclusivity.
Receiving the 3-Year Exclusivity means that a competitor, such as an Abbreviated New Drug Application (ANDA) or 505(b)(2) NDA applicant, cannot rely on the protected clinical investigation until the exclusivity expires three years after approval, but it may obtain FDA approval for unprotected conditions of use. For example, by “carving out” exclusivity protected information from the label of the reference listed drug that an ANDA seeks to duplicate.4
The guidance also addresses when comparator studies can qualify for exclusivity. In scenarios where a study involves at least one different cohort or treatment arm compared to a previously approved application, such investigation may qualify as a new clinical investigation for the exclusivity if:
- the cohort or treatment arm could be characterized as a clinical investigation,
- the FDA has not previously relied on the results of that specific cohort or treatment arm to demonstrate substantial evidence of effectiveness of a previously approved drug product for any indication or of safety for a new patient population, and
- the results do not duplicate those of another investigation that was relied on by the FDA to demonstrate the effectiveness or safety in a new patient population of a previously approved drug product.
The FDA notes that it will take a multifactorial approach to reviewing exclusivity requests to incentivize sponsors to design trials efficiently and to submit results from distinct cohorts or treatment arms as soon as they are available instead of delaying approval until all the results from all the cohorts or treatment arms are available for supporting a broader scope for exclusivity.
In general, a study must measure clinical safety or efficacy endpoints to qualify for exclusivity.5 Studies that measure pharmarcokinetics (PK), pharmacodynamics, or bioequivalence alone do not qualify, while studies that assess both PK/bioavailability and clinical safety and/or effectiveness may qualify as a new clinical investigation for the 3-Year Exclusivity.6
The guidance also describes how applicants should request exclusivity and provides a template to request 3-Year Exclusivity in an NDA.7
For additional information concerning regulatory exclusivity, or other FDA programs and FDA regulatory strategies, please contact Wilson Sonsini attorneys Eva F. Yin or Daniel E. Orr.
[1] U.S. Food and Drug Administration, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers Guidance for Industry (Mar. 2026), available at: https://www.fda.gov/media/191368/download.
[3] 21 U.S.C. § 355(c)(3)(E)(iii), (j)(5)(F)(iii).
[4] New Clinical Investigation Exclusivity, note 1 above, at 8.
