FDA Draft Guidance on 3-Year Exclusivity for Drug Products

Detected March 4th, 2026

Summary

The FDA has issued draft guidance to assist applicants requesting 3-year exclusivity for drug products. The guidance, available for public comment, clarifies the statutory and regulatory criteria for eligibility and provides recommendations on request content and format. This aims to support the Drug Competition Action Plan.

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What changed

The FDA has released a draft guidance document titled "New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers" (Docket Number: FDA-2024-D-4388). This guidance is intended to help applicants understand and request the 3-year exclusivity for new drug applications (NDAs) or NDA supplements. It details the eligibility criteria and offers recommendations on the necessary content and format for such requests, presented in a Q&A format.

This draft guidance is open for public comment. Regulated entities, particularly pharmaceutical companies and drug manufacturers, should review the guidance to understand the requirements for seeking 3-year exclusivity. Comments can be submitted online via regulations.gov or by mail to Dockets Management. While no specific compliance deadline is mentioned for the guidance itself, understanding these requirements is crucial for future drug application strategies. The FDA intends to update this guidance with additional Q&As as needed.

What to do next

Review the draft guidance on 3-year exclusivity for drug products.
Submit comments on the draft guidance via regulations.gov or mail by the specified deadline.
Update internal procedures for requesting 3-year exclusivity based on final guidance.

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Guidance Documents

Docket Number: FDA-2024-D-4388 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and provides recommendations on the content and format of requests for 3-year exclusivity in the form of questions and answers (Q&As). FDA intends to update this draft guidance document to include additional Q&As as appropriate.