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Cumberland wins patent case involving Acetadote against Mylan

The U.S. Court of Appeals for the Federal Circuit ruled in favor of Cumberland Pharmaceuticals Inc. in a patent case involving its Acetadote product.

The court upheld the validity of the patent, which will remain in force until August 2025.

The ruling affirmed the Sep. 30, 2015, decision reached by the United States District Court for the Northern District of Illinois, in which the court upheld Cumberland's patent, rejecting a validity challenge from Mylan NV's Mylan Inc. and Mylan Institutional LLC.

Cumberland's patent that was challenged had claims associated with Acetadote's formulation that it is substantially free of chelating or stabilizing agents. Mylan infringed the patent by filing an abbreviated new drug application of its generic version of Acetadote.

On Oct. 30, 2015, Mylan filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit. The district court entered an order on Nov. 17, 2015, enjoining Mylan and its affiliates from selling or using its generic version of Acetadote until Cumberland's patent expires.

Acetadote is indicated for the treatment of acetaminophen poisoning in the U.S. Acetaminophen is a medication used to relieve pain and fever.