Impax Labs Confirms Patent Challenge Relating To Generic Atelvia

(RTTNews) - Impax Laboratories, Inc. (IPXL) confirmed Friday that it has initiated a challenge of the patents listed in the Orange Book in connection with Atelvia delayed-release tablets, 35 mg.

Impax filed its Abbreviated New Drug Application containing a paragraph IV certification for a generic version of Atelvia with the U.S. Food & Drug Administration. Following receipt of the notice from FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of the paragraph IV certification.

On October 23, Warner Chilcott Company, LLC and Warner Chilcott (US), LLC filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey. The action formally initiates the patent challenge process under the Hatch-Waxman Act.

Once the ANDA is approved by the FDA, Global Pharmaceuticals, Impax's generic division, plans to commercialize the product.

According to IMS Health, U.S. sales of Atelvia, 35 mg, were about $74 million for the 12 months ended August.