Court Validates Cumberland’s Patent for Overdose Drug Acetadote in Dispute with Mylan

The U.S. Court of Appeals for the Federal Circuit affirmed Cumberland Pharmaceuticals’ patent for its second-generation version of Acetadote, barring Mylan from marketing a generic of the overdose therapy.

A three-judge panel for the appeals court upheld a district court ruling from 2015 that validated a patent covering a formulation of Acetadote, which does not contain the stabilizing agent edetate, and found Mylan infringed the patent when seeking approval for a generic version.

The ruling stems from a lawsuit Cumberland filed in 2012, alleging Mylan’s ANDA violated the patent that expires in 2025.