Assertio Therapeutics: Gets favorable ruling in NUCYNTA patent litigation

Assertio Therapeutics (ASRT) announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of Assertio with respect to the company’s patent litigation against three filers of Abbreviated New Drug Applications for the NUCYNTA franchise. The Federal Circuit’s ruling affirms the decision of the United States District Court, which found U.S. patent No. 7,994,364 to be valid and infringed by the defendants. The ‘364 Patent covers the entire NUCYNTA franchise until December 2025. With the Court’s ruling, the company expects market exclusivity until December 2025 for NUCYNTA ER, NUCYNTA and NUCYNTA oral solution. The NUCYNTA franchise is commercialized by Collegium Pharmaceutical (COLL). The company receives royalties from Collegium based on net sales of the franchise. Based on Collegium’s current 2019 NUCYNTA franchise revenue guidance, the Company currently expects such royalties to be approximately $120M in 2019. The Federal Circuit affirmed the District Court’s ruling with regard to U.S. patent No. 8,536,130 which upheld the validity of the ‘130 Patent but found that two of the three ANDA filers do not infringe the patent. The ‘130 Patent covers NUCYNTA ER until March 2029. The defendants in the appeal of the District Court’s ruling in the patent litigation included Alkem Laboratories Limited, Hikma Pharmaceuticals International Limited and Actavis Elizabeth LLC, along with certain of their affiliated companies.

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