Depomed Announces District Court Order in ANDA Litigation
Opinion Expected “In Short Order”
NEWARK, Calif., July 17, 2014 /PRNewswire/ — Depomed, Inc. (Nasdaq: DEPO) today announced that on July 17, 2014, Judge Joel A. Pisano of the United States District Court for the District of New Jersey entered an order preliminarily enjoining Actavis Elizabeth LLC and Actavis Inc. from marketing a generic version of Gralise® (gabapentin) prior to the Court’s issuance of an opinion in the matter. The order indicates the Court expects to issue an opinion in short order. The patents asserted in the lawsuits expire between September 2016 and February 2024 and include U.S. Patent Nos. 6,635,280; 6,488,962; 7,438,927; 7,731,989; 8,192,756; 8,252,332; and 8,333,992.
On May 20, 2014, a bench trial was completed before Judge Pisano in the patent litigation between Depomed and defendants Actavis Elizabeth LLC and Actavis Inc. related to an Abbreviated New Drug Application filed by Actavis seeking to market generic versions of 300mg and 600mg dosage strengths of Gralise prior to the expiration of the patents asserted in the litigation.
Depomed 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. 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). Zipsor(®) (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda(®) (fentanyl) Nasal Spray 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 the outcome of the Actavis litigation 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, 2014 and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. 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.