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IMPAX Laboratories, Inc. (IPXL) Sued Based on ANDA for Generic Ultram(R) ER
8/12/2008
HAYWARD, Calif.--(BUSINESS WIRE)--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.
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