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July 24, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with OSI, Pfizer and Genentech that will resolve patent litigation related to Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg. This product is the generic version of TARCEVA
®, and is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, had U.S. sales of approximately
$638.7 million for the 12 months ending
March 31, 2013, according to IMS Health.
Currently, Mylan has 174 ANDAs pending FDA approval representing
$83.2 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing
$23 billion in annual brand sales, for the 12 months ending
Dec. 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.