NEWARK, Calif., Sept. 30, 2016 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that Judge Claire C. Cecchi of the United States District Court for the District of New Jersey has ruled in favor of Depomed in the company's patent litigation against all three filers of Abbreviated New Drug Applications (ANDAs) for Depomed's NUCYNTA franchise. With the court’s ruling, Depomed expects market exclusivity until December 2025 for NUCYNTA® ER, NUCYNTA® and NUCYNTA® oral solution (an unmarketed form of NUCYNTA). 1
“We are pleased with the Court’s decision as it confirms the validity and strength of the NUCYNTA patents,” said Jim Schoeneck, President and CEO of Depomed. “We look forward to growing the NUCYNTA franchise, comprised of two important and highly-differentiated medicines, for at least the next 9 years.”
The court found U.S. patent Nos. 7,994,364 and RE39,593 to be valid and infringed by the defendants. The patents cover the entire NUCYNTA franchise and will expire on December 27, 2025 and February 5, 2023, respectively.1 Judge Cecchi upheld the validity of U.S. Patent No. 8,536,130 (the “130 Patent”), but found that two of the three filers do not infringe the patent. The ‘130 Patent covers NUCYNTA ER until March 2029. 1 The company intends to appeal the court’s finding as it relates to infringement of the ‘130 Patent.
The defendants in the litigation included Actavis Inc., Alkem Laboratories Limited and Roxane Laboratories, Inc., along with certain of their affiliated companies. All three defendants filed ANDAs for NUCYNTA ER and NUCYNTA. An affiliate of Actavis filed an ANDA for NUCYNTA oral solution.
Depomed is a leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California. To learn more about Depomed, visit 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 commercialization of NUCYNTA ER and NUCYNTA, expectations regarding pediatric extensions applicable to the patents asserted in the litigation and other risks detailed in the company's Securities and Exchange Commission filings, including the company's most recent 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. 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.
1 Patent expiration dates reflect the addition of six months of pediatric patent term extension that Depomed anticipates securing from the FDA.
INVESTOR CONTACT: Christopher Keenan VP, Investor Relations and Corporate Communications Depomed, Inc. 510-744-8000 firstname.lastname@example.org