Alvogen Pine Brook LLC (“Alvogen”), and subsequently Lotus Pharmaceutical (“Lotus”), confirmed today that it has launched Buprenorphine and Naloxone Sublingual Film in the United States. The product comes in 4 strengths (2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg) and is a generic equivalent of Suboxone® sublingual film. The launch took place following the issuance of mandate from U.S. Court of Appeals for the Federal Circuit (“CAFC”) to vacate the preliminary injunction (“PI”) granted against Dr. Reddy’s Laboratories (“DRL”) based on U.S. Patent No. 9,931,305.
Alvogen obtained final approval from the U.S. Food and Drug Administration (“USFDA”) on January 24th for the generic alternative of Suboxone® sublingual film for the treatment of adults with opioid dependence and addiction. Based on the agreement with Indivior dated January 31st, the Temporary Restraining Order (“TRO”) granted to Indivior by U.S. District Court for the District of New Jersey against Alvogen on January 24th can no longer enjoin Alvogen from the use, offer to sell, or sale within the United States now that the mandate has been issued to vacate DRL’s PI.
Robert Wessman, Chairman of both Alvogen and Lotus, commented: