Healthcare Industry News: Janssen
News Release - September 15, 2015
Depomed Files New Patent Infringement Lawsuit Against NUCYNTA(R) ER ANDA FilerNEWARK, Calif., Sept. 15, 2015 -- (Healthcare Sales & Marketing Network) -- Depomed, Inc. (DEPO) today announced that it has filed a new patent infringement lawsuit in the United States District Court for the District of New Jersey against Actavis Elizabeth LLC, Actavis, Inc. and Actavis LLC ("Actavis"). Actavis previously filed an Abbreviated New Drug Application (ANDA) with the FDA to market generic Nucynta® ER (tapentadol hydrochloride, extended release) tablets and it served Paragraph IV certifications on the patents then listed in FDA's Orange Book for Nucynta® ER. At the time, Janssen Pharmaceuticals, Inc. owned the rights to Nucynta® ER and it filed a patent infringement suit against Actavis. Subsequently, U.S. Patent No. 8,536,130 ("'130 patent") issued and was listed in the Orange Book for Nucynta® ER, but Actavis did not file a Paragraph IV certification on this patent. In its new lawsuit, Depomed claims that Actavis's proposed generic product would infringe the '130 patent if its generic products are approved. The '130 patent does not expire until September 22, 2028, subject to additional exclusivity for pediatric studies.
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, Nucynta ER 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.
NUCYNTA®, Gralise® CAMBIA®, Zipsor®, Lazanda® and Acuform® are registered trademarks of Depomed, Inc.
"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 uncertainties of intellectual property litigation and enforcement of patent claims and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. 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. The achievement of those plans and objectives involves risks and uncertainties including, but not limited to, risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. 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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