Healthcare Industry News: migraine
News Release - April 13, 2015
Depomed Announces Gralise(R) ANDA Litigation Settlement Confirming Exclusivity to 2024 and Dismissing AppealNEWARK, Calif., April 13, 2015 -- (Healthcare Sales & Marketing Network) -- Depomed, Inc. (DEPO) today announced it has entered into a settlement agreement with Actavis, Inc. in Depomed's patent infringement litigation related to Actavis's Abbreviated New Drug Application seeking approval to market generic versions of Depomed's Gralise® (gabapentin) 300 mg and 600 mg tablets. The settlement permits Actavis to begin selling generic versions of Gralise on January 1, 2024, or earlier under certain circumstances.
"We are pleased with this settlement, as it confirms the expected period of market exclusivity for Gralise and avoids the expense of an appeal," commented Jim Schoeneck, President and Chief Executive Officer of Depomed.
The settlement dismisses Actavis's pending appeal with the United States Court of Appeals for the Federal Circuit of the August 2014 trial court decision finding all seven Depomed patents asserted in the litigation, which expire between 2016 and February 2024, to be valid and infringed. The settlement agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, and entry of orders dismissing the appeal and related federal district court litigation.
In April 2014, Depomed announced settlements with two other Gralise ANDA filers providing for generic entry on January 1, 2024. Upon dismissal of the Actavis litigation, all pending Gralise ANDA litigation will have been resolved.
Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. 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 risks related to the settlement agreement with Actavis, including any legal or regulatory challenge to the settlement agreement 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, 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.
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