Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer’s Detrol LA (tolterodine tartrate) extended-release (ER) capsules, pending final approval by FDA.
Pfizer announced, in a Sept. 7, 2012, press release, that it has settled its litigation against Mylan and its subsidiary, Mylan Pharmaceuticals, regarding Pfizer’s patents covering Detrol LA (tolterodine tartrate) extended-release capsules. According to the agreement, Mylan may begin to sell its generic version on Jan. 1, 2014, subject to final approval by FDA.
Mylan had submitted an abbreviated new drug application (ANDA) for 2- and 4-mg tolterodine tartrate ER capsules, which are the generic version of Detrol LA. The drug is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The agreement allows Mylan to launch the product as either an authorized generic or under its own ANDA, stated the company in a Sept. 7, 2012, press release. The agreements are subject to review by the US Federal Trade Commission and the US Department of Justice.