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.
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius, LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2022.