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Mylan Confirms First-to-File Patent Challenge Relating to Vivelle-Dot®
Date:3/1/2011

PITTSBURGH, March 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. This product is the generic version of Vivelle-Dot®, which is indicated for the treatment of symptoms associated with menopause, the treatment of hypoestrogenism and the prevention of postmenopausal osteoporosis.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for all strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont.

Vivelle-Dot had U.S. sales of approximately $215 million for the 12 months ending Dec. 31, 2010, according to IMS Health. Currently, Mylan has 169 ANDAs pending FDA approval representing $97.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $24.8 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first-to-file status and pending litigation. 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
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SOURCE Mylan Inc.
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