MIAMI & NEW YORK--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc. today provided an update on the status of its pending Abbreviated New Drug Application (ANDA) seeking approval to market a lidocaine topical patch 5%. Noven’s lidocaine topical patch 5% is a generic version of Endo Pharmaceuticals’ Lidoderm®.
As previously announced, on May 15, 2012, Noven notified Endo and its partners (Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA) under the Hatch-Waxman Act that Noven’s ANDA had been accepted for review by the FDA and that it included a paragraph IV certification.
Under the Hatch-Waxman Act, the filing of an ANDA containing a paragraph IV certification gives a patent holder the right to commence a pre-approval patent lawsuit in the U.S. federal courts. Accordingly, earlier today Endo and its partners filed suit against Noven in the U.S. District Court for the District of Delaware seeking to prevent Noven from commercializing its lidocaine topical patch 5% prior to the expiration of certain U.S. patents. Under the Hatch-Waxman Act, the lawsuit prevents final FDA approval of Noven’s ANDA for 30 months from the date Endo’s partners received notice of Noven’s ANDA or until the court declares that the asserted patents are invalid, unenforceable or not infringed, whichever occurs earlier.
Lidoderm® is indicated for relief of pain associated with post-herpetic neuralgia. Lidoderm® is a registered trademark of Hind Health Care, Inc.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Noven’s products include Vivelle-Dot® (estradiol transdermal system), the most prescribed transdermal estrogen therapy product in the U.S., and Daytrana® (methylphenidate transdermal system), the first and only transdermal patch approved for ADHD. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. For more information about Noven, visit www.noven.com.