Mylan Inc. (MYL) announced that the company and its subsidiary, Mylan Pharmaceuticals Inc., inked a settlement agreement with Pfizer Inc. (PFE), Pharmacia & Upjohn Co. LLC and Pfizer Health AB that will resolve the parties' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application, or 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.
As per the terms of the settlement agreement, Mylan may start selling 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.
by RTT Staff Writer
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