Depomed Announces Settlements with Two Gralise® ANDA Filers
NEWARK, Calif., April 14, 2014 /PRNewswire/ — Depomed, Inc. (Nasdaq: DEPO) today announced it has entered into settlement agreements with two of the three defendants involved in Depomed’s ongoing patent infringement litigation against filers of Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of Depomed’s Gralise(®) (gabapentin) 300 mg and 600 mg tablets. The settlements permit the defendants to begin selling generic versions of Gralise on January 1, 2024, or earlier under certain circumstances. The patent litigation continues against Actavis, the other Gralise ANDA filer.
The settlements involve Incepta Pharmaceuticals Co. Ltd. and Zydus Pharmaceuticals (USA), Inc., as well as their affiliated co-defendants. The agreements are subject to review by the U.S. Department of Justice and the Federal Trade Commission, and entry of an order dismissing the litigation by the U.S. District Court for the District of New Jersey.
Depomed, Inc. is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Gralise(®) (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. Zipsor(®) (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. CAMBIA(®) (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Lazanda(®) (fentanyl) Nasal Spray (CII) is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise and various partner product candidates are formulated with Depomed’s proven, proprietary Acuform(®) drug delivery technology. Additional information about Depomed may be found at 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 risks related to the settlement agreements with Gralise ANDA filers, including any legal or regulatory challenge to the settlement agreements by the U.S. Department of Justice and/or the Federal Trade Commission, and the outcome of any such challenge; 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, 2013. 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
Canale Communications for Depomed
SOURCE Depomed, Inc.