An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

Understand the generic drug approval pathway and requirements of sameness, bioequivalence, and therapeutic equivalence. Recognize patent listing and certification requirements and implications for Hatch-Waxman patent infringement cases and generic drug approval. Learn eligibility requirements and scope of various market exclusivities for innovator and generic products.

Joshua Weinger, Partner, Goodwin Procter LLP

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023.

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An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

A session from FDLI's Introduction to Drug Law and Regulation Recorded November 15–16, 2023

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A session from FDLI's Introduction to Drug Law and Regulation
Recorded November 15–16, 2023