MENLO PARK, Calif., July 2, 2013 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today announced that it has received a Paragraph IV certification notice from Banner Pharmacaps Inc. advising Depomed that Banner has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Zipsor® (diclofenac potassium) liquid filled capsules, 25 mg. Banner's certification notice alleges that the five U.S. Patents listed in the FDA Orange Book for Zispor, will not be infringed by Banner's proposed product, or are invalid and/or are unenforceable. Four of the patents expire in 2029 and one expires in 2019.
According to Banner's certification notice, Banner has granted to Watson Laboratories, Inc. the exclusive right to sell, market, distribute, or otherwise commercialize Banner's ANDA product.
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 Banner that would automatically stay, or bar, the FDA from approving the ANDA for 30 months after Depomed's receipt of the Paragraph IV certification or until a district court decision that is adverse to the company, whichever is earlier.
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. 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. The company 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.
"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 enforcement of our 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 for the year ended December 31, 2012 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. 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.
CONTACT: August J. Moretti Depomed, Inc. 510.744.8000 firstname.lastname@example.org
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