FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Invidior Plans to Appeal Verdict in Suboxone Patent Case

Sept. 11, 2017
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Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence.

The U.S. District Court for the District of Delaware ruled that a generic version of Suboxone proposed by Dr. Reddy’s Laboratories does not infringe on Indivior’s patent.

Dr. Reddy’s version of the medication uses a different polymer for the film that serves as the vehicle for delivery of the active ingredients. Although that variation was described as an alternative in the original 2011 patent for Suboxone, it was not claimed as part of the patent itself, the court said, and therefore is not entitled to protection.

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