About this episode

The episode discusses the case of Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. regarding the approval of a generic version of Vascepa.

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. Justia · Docket · oyez.org Petitioner: Hikma Pharmaceuticals USA Inc. Respondent: Amarin Pharma, Inc. Facts of the case (from oyez.org) Amarin Pharma markets icosapent ethyl under the brand name Vascepa. In 2012, the FDA approved Vascepa for treating severe hypertriglyceridemia (the SH indication), which affects patients with blood triglyceride levels of at least 500 mg/dL. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: reducing cardiovascular risk in patients with triglyceride levels of at least 150 mg/dL (the CV indication). Amarin listed two patents covering the CV indication in the FDA’s Orange Book. In 2016, Hikma Pharmaceuticals submitted an Abbreviated New Drug Application seeking approval for a generic version of icosapent ethyl. When the CV indication was approved in 2019, Hikma filed a “section viii statement” seeking FDA approval only for the SH indication by “carving out” the patented CV indication from its label—creating a “skinny label.” The FDA approved Hikma’s ANDA in May 2020. Throughout 2020, Hikma issued press releases referring to its…

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