MENLO PARK, Calif., Jan. 23, 2012 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that it has received a Paragraph IV certification notice from Actavis Elizabeth LLC advising Depomed that Actavis has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Gralise™ (gabapentin), 300 mg and 600 mg tablets. Actavis' certification notice alleges that Depomed's six US patents for Gralise listed in the FDA Orange Book, the latest of which expires in 2024, will not be infringed by Actavis' proposed product, or are invalid and/or are unenforceable.
Depomed is evaluating the Paragraph IV certification and intends to vigorously enforce its intellectual property rights. Depomed has 45 days from the receipt of the Paragraph IV certification to commence a patent infringement lawsuit against Actavis that would automatically stay, or bar, the FDA from approving Actavis' ANDA for 30 months or until a district court renders a decision that is adverse to Depomed, whichever is earlier.
"We are confident in the intellectual property estate around our Gralise product," commented James A. Schoeneck, Depomed's President and CEO. "We have six Orange Book listed patents for Gralise and more than 10 patent applications in prosecution. Also, Gralise has received Orphan Drug designation, and we continue to pursue Orphan Drug exclusivity for the product," Mr. Schoeneck added.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with two approved and marketed products. Gralise™ (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 enforcement of the company's intellectual property rights 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 and uncertainties related to the outcome of any patent litigation related to Gralise; the launch and market acceptance of Gralise; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; 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. 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.