Depomed Files New Patent Infringement Lawsuit Against NUCYNTA ER ANDA Filer

Depomed, Inc.

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.