Depomed Prevails in Gralise® ANDA Litigation Blocking Generic Entry Until 2024
NEWARK, Calif., Aug. 19, 2014 /PRNewswire/ -- Depomed, Inc. (DEPO) today announced Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey has ruled in favor of Depomed in the company's patent litigation lawsuit against Actavis, Inc. related to Actavis's Abbreviated New Drug Application for generic versions of Depomed's Gralise® (gabapentin) tablets for the management of postherpetic neuralgia.
Judge Pisano's ruling finds that Actavis infringes all seven Depomed patents asserted and upholds the validity of the patents. The latest expiration of the infringed patents is February 2024.
"We are pleased with this decision, as it confirms the innovation of Gralise and the strength of our patents. This ruling provides for nearly 10 years of additional market exclusivity," commented Jim Schoeneck, President and Chief Executive Officer of Depomed. "We look forward to providing Gralise to postherpetic neuralgia patients and their physicians well into the next decade."
Depomed previously announced settlements with two other Gralise ANDA filers providing for generic entry on January 1, 2024.
Depomed is a specialty pharmaceutical company that commercializes products for pain and CNS 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 atwww.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 June 30, 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