Depomed Announces Dismissal Of Suit Against Two Gralise ANDA Filers Following Withdrawal Of ANDA And Patent Challenge
NEWARK, Calif., Dec. 26, 2012 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that its lawsuits against two filers of Abbreviated New Drug Applications (ANDAs) for Gralise ® (gabapentin) have been dismissed. Watson Laboratories has withdrawn its Gralise ANDA. Par Pharmaceutical has amended its Gralise ANDA and is no longer seeking approval of the ANDA prior to the expiration of Depomed's patents listed for Gralise in the FDA publication commonly known as the Orange Book. As a result, the U.S. District Court for the District of New Jersey has granted the parties' request for dismissal of Depomed's lawsuits against Watson and Par for infringement of Depomed's Gralise patents. As previously disclosed, in October 2012 Depomed's patent lawsuit against Impax was dismissed following Impax's withdrawal of its Gralise ANDA.
Depomed's patent litigation against the remaining three Gralise ANDA filers continues in the U.S. District Court for the District of New Jersey.
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. 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.
"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 our ongoing patent ligation related to Gralise, 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, 2011 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. 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.
August J. Moretti
SOURCE Depomed, Inc.
Web Site: http://www.depomed.com
Posted: December 2012