PITTSBURGH, Sept. 7, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) 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.This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.