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Thursday, December 20, 2018

Aquestive Therapeutics, Indivior filing petition for rehearing on CAFC ruling


Aquestive Therapeutics, Indivior filing petition for rehearing on CAFC ruling  Aquestive (AQST) and (INVVY) are filing a petition with the U.S. Court of Appeals for the Federal Circuit for a rehearing by the original panel of judges, as well as a rehearing en banc, on the CAFC’s ruling to vacate the preliminary injunction granted by the U.S. District Court of New Jersey to enjoin Dr. Reddy’s Laboratories (RDY) from launching its generic buprenorphine/naloxone sublingual film product, which utilizes Aquestive’s PharmFilm technology. The PI will remain in place to enjoin DRL’s “at-risk” entry into the U.S. market, until the CAFC rules on the joint petition. This decision will have no impact on the core Aquestive patent portfolio. Aquestive’s Suboxone revenues are driven by order volume from both branded and authorized generic products. Aquestive has a sole and exclusive worldwide manufacturing agreement with Indivior for both branded and authorized generic Suboxone and will continue to fulfill non-U.S. orders, which also continue to grow as a percent of total Suboxone business.

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