Mylan Inc. today announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Pfizer Inc., Pharmacia & Upjohn Company LLC and Pfizer Health AB that will resolve the parties’ patent litigation in connection with Mylan Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for Tolterodine Tartrate ER capsules, 2 mg and 4 mg, which is the generic version of Pfizer’s Detrol LA, indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
According to the terms of the settlement agreement, Mylan may begin to sell the product on January 1, 2014, or earlier under certain limited circumstances, and no later than March 1, 2014, subject to final approval from the U.S. Food and Drug Administration. Under the terms of the agreement, Mylan may launch the product as either an authorized generic or under its own ANDA. Pursuant to the agreement, the pending litigation will be dismissed.
Other details of the settlement are confidential, and the agreements are subject to review by the Federal Trade Commission and the U.S. Department of Justice.
Tolterodine Tartrate ER capsules, 2 mg and 4 mg, had U.S. sales of approximately $599 million for the 12 months ending June 31, 2012, according to IMS Health.
