MIAMI & NEW YORK--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court of Delaware against Actavis Laboratories UT, Inc. ("Actavis") for patent infringement.
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 Minivelle® (estradiol transdermal system) prior to the expiration of the Orange Book listed 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 Actavis' Paragraph IV Certification Notice Letter, the FDA cannot approve Actavis’ ANDA for 30 months (until August 2017), unless the district court decides before the 30 months pass that the patent is invalid or not infringed.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven’s mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery. For more information about Noven, visit www.noven.com.