May 11, 2023

FDA Lifecycle Management Webinar Series: 3-Year “New Clinical Investigation” Exclusivity


Join Mayer Brown FDA regulatory partner George O’Brien and associate Ryan Babcock for this installment of our FDA Lifecycle Management webinar series. In this webinar, George and Ryan will discuss the FDA’s 3-year “new clinical investigation” exclusivity provisions.

3-year exclusivity under the Hatch-Waxman Act plays a critical role in extending the lifecycle of approved drug products and protecting innovative uses of re-purposed drugs. However, there are also some common pitfalls and limitations that need to be understood, including uncertainty surrounding the scope of 3-year exclusivity.

Specifically, we will discuss:

  • An overview of the statutory and regulatory eligibility criteria for 3-year exclusivity;
  • A summary analysis of key FDA precedents and case law regarding the scope of 3-year exclusivity, including the signs of a potential trend towards narrowing the exclusivity; and
  • A review of practical strategies for obtaining 3-year exclusivity. 

For additional information, please contact Hilda Macauley at or +1 202 263 3047.

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