Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with OSI, Pfizer and Genentech that will resolve patent litigation related to Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg. This product is the generic version of TARCEVA®, and is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, had U.S. sales of approximately $638.7 million for the 12 months ending March 31, 2013, according to IMS Health.
Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $23 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.