Pfizer Settles Patent Litigation with Mylan
Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer's Detrol LA (tolterodine tartrate) extended-release capsules, pending final approval by FDA.
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.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
