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Pharmaceutical Industry › Food and Drug Administration (FDA) › Carve Out Provisions

Hogan Lovells

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

Hogan Lovells on

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Biosimilar Guidance for Label Carve-Outs and Supplements

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more

McGuireWoods LLP

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

McGuireWoods LLP on

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

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