Noven Pharmaceuticals has filed a lawsuit in the U.S. District Court of New Jersey against Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Andrx Corp., and Actavis, Inc. for infringement of certain Noven patents.
The lawsuit was filed as a result of Actavis submitting an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) in which Actavis is seeking approval to market and sell a generic version of Brisdelle ® (paroxetine) capsules prior to the expiration of the Patents. The lawsuit reflects Noven’s commitment to vigorously defend its intellectual property rights against infringement.
Under the Hatch-Waxman Act, because Noven filed this patent infringement lawsuit within 45 days of receiving the Paragraph IV Certification Notice, the FDA cannot approve Actavis’ ANDA for 30 months (until March 2017), unless the district court decides before the 30 months pass that the Patents are invalid or not infringed. Brisdelle ® is protected by three Orange Book listed patents, which expire in 2017, 2023 and 2029, respectively. In addition, Brisdelle ® has marketing exclusivity that prevents FDA approval of an ANDA prior to June 2016.