MENLO PARK, Calif., March 5, 2012 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced it has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against three companies that have filed Abbreviated New Drug Applications with the FDA to market generic Gralise® (gabapentin), Depomed's once-daily gabapentin product for the management of postherpetic neuralgia.
The lawsuit claims infringement of Depomed's six US patents listed for Gralise in the FDA's Orange Book, the last of which expires in 2024, by each defendant's proposed generic product. Depomed has received a Paragraph IV certification notice from each defendant alleging that Depomed's patents will not be infringed by the proposed generic product, or the patents are invalid or unenforceable. The defendants in the lawsuit are: Actavis Elizabeth LLC and an affiliated company; Watson Laboratories Inc. – Florida and affiliated companies; and Incepta Pharmaceuticals Co. Ltd.
Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the Gralise ANDAs for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.
Depomed, Inc. is a specialty pharmaceutical company with two approved and marketed products. GraliseTM (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the uncertainties of intellectual property litigation and enforcement of patent claims and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. The achievement of those plans and objectives involves risks and uncertainties including, but not limited to, risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
August J. Moretti Depomed, Inc. 650-462-5900