FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

N.J. Court Delays Launch of Alvogen’s Suboxone Generic

Feb. 1, 2019

A federal court in New Jersey issued a restraining order on Friday temporarily blocking the release of a generic version of Indivior’s opioid dependence drug Suboxone (buprenorphine and naloxone) sublingual film.

The U.S. District Court for the District of New Jersey barred Alvogen from launching its generic pending a February 7 preliminary injunction hearing in which the two companies will present their evidence.

UK-based Indivior has been fiercely protective of its flagship drug since receiving a new patent in 2018, aggressively challenging alleged infringers — including Alvogen — to keep their generic versions off the market. Indivior claimed Teva, Actavis, Dr. Reddy’s, Par and Alvogen infringed on a patent issued on Jan. 2, 2018.

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