On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more
On February 24, 2023, the Federal Circuit held that Jazz Pharmaceuticals, Inc. (Jazz) must delist U.S. Patent No. 8,731,963 (the ’963 Patent) from the U.S. Food and Drug Administration’s (FDA’s) “Orange Book” because the...more
On July 28, 2021, the U.S. Food and Drug Administration (FDA) announced a landmark approval of Viatris Inc.’s Semglee® as the first interchangeable biosimilar product. Semglee® (insulin glargine-yfgn), indicated to control...more
On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more
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Biosimilars ,
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Commercial Marketing ,
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Sandoz v Amgen ,
Unfair Competition