Mylan confirmation before File patent challenge relating to FROVA tablets expects to qualify for 180-day marketing exclusivity

PITTSBURGH, August 17, 2011/PRNewswire via COMTEX/--Mylan Inc. (Nasdaq: MYL) today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been denounced by Endo Pharmaceuticals in connection with the filing of an abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan succinate EQ, 2.5 mg tablets. This product is the generic version of Frova, which is indicated for the treatment of symptoms associated with acute migraine with or without aura in adults.Mylan believes is the first company to have deposited a substantially complete ANDA containing a paragraph IV certification and expects to qualify for 180-day marketing exclusivity on final approval of the FDA. The plaintiffs filed the lawsuit in the United States District Court for the District of Delaware. For the 12 months ending on June 30, 2011, Endo was Frova turnover of 68,197 million dollars, according to IMS Health. Mylan has currently 162 ANDAs awaiting FDA approval, representing 94.4 billion dollars in annual sales. Forty-three of these pending ANDAs, including Frovatriptan succinate EQ, are potential opportunities of the first file, which is 25.5 billion of annual sales by brand, for the 12 months ending on June 30, 2011, according to IMS Health. This press release contains statements that constitute "forward-looking statements", including with regard to the expected state of the first file 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 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: the use of legal strategies, regulations and laws by competitors or other third parties to delay or prevent the introduction of products; risks related to legal and regulatory processes; and other risks detailed in the documentation of the company 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.Mylan Inc. ranks among generics and specialty pharmaceutical companies in the world and supplies products to customers in over 150 countries and territories. The company maintains one of the widest product portfolios and high quality of the field supported by a robust product pipeline; artwork of one of the largest pharmaceutical manufacturers active in the world; and runs that a specialty company focused on respiratory, allergic and psychiatric therapies. For more information about Mylan, visit www.mylan.com. For more information on generics, visit www.ChoosingGenerics.com.SOURCE Mylan Inc. www.prnewswire.com Copyright (C) 2011 PR Newswire. All rights reserved-0-keyword: Pennsylvania industry KEYWORD subject: HEAPHAMTC code: LAWPLW

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