Mylan and its subsidiary, Mylan Pharmaceuticals, have signed a settlement agreement with Pfizer, Pharmacia & Upjohn Company and Pfizer Health related to Detrol LA patent litigation.
The litigation is related to Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Tolterodine Tartrate ER capsules, 2mg and 4mg, the generic version of Pfizer's Detrol LA, indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
The settlement dismisses the pending litigation and allows Mylan to start selling the generic product on 1 January 2014, or earlier under certain limited circumstances, and 1 March 2014, subject to final FDA approval.
The agreements are subject to review by the Federal Trade Commission and the US Department of Justice. Other details of the settlement were not revealed.
