IMPAX sued for patent infringement on generic Ultram ER

Aug 12 2008

IMPAX Laboratories, Inc. today announced Purdue Pharma Products L.P. ("Purdue"), Napp Pharmaceutical Group Ltd. ("Napp"), Biovail Laboratories International, SRL ("Biovail") and Ortho-McNeil, Inc. ("Ortho-McNeil") have filed suit for patent infringement in the United States District Court for the District of Delaware based on the Company's submission of its Abbreviated New Drug Application ("ANDA") for tramadol hydrochloride extended-release tablets (100 mg), generic of Ultram ER, to the Food and Drug Administration.

In connection with this ANDA, IMPAX provided notice to Purdue, Napp, Biovail and Ortho-McNeil that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid or enforceable claim of U.S. Patent No. 6,254,887.

Ultram ER tablets are indicated for the treatment of moderate to moderately severe chronic pain. According to Wolters Kluwer Health, U.S. sales of Ultram ER 100 mg tablets were approximately $62 million in the 12 months ended June 2008.

IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities.