Noven Pharmaceuticals, Inc. today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5%. Noven’s lidocaine topical patch 5% is a generic version of Endo Pharmaceuticals’ Lidoderm®.
On May 15, 2012, pursuant to the Hatch-Waxman Act, Noven notified Endo and its partners (Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA) that Noven’s ANDA had been accepted for review by the FDA and includes 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. If the patent holder initiates such an action within 45 days of receiving notice of the filing, the FDA must refrain from approving the ANDA for 30 months, or until a district court decision declaring 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 business and operations include transdermal drug delivery and related manufacturing, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit. 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.