Impax defends aNDA for generic Effexor XR in wake of Wyeth lawsuit

By Lisa Kerner

Erie, Pa., April 7 - Impax Laboratories, Inc. said that Wyeth has filed a lawsuit against the company in the U.S. District Court for the District of Delaware alleging patent infringement related to Impax's filing of an abbreviated New Drug Application for generic versions of Effexor XR 37.5 mg, 75 mg and 150 mg capsules.

Impax's submission includes a paragraph IV certification stating it believes the product does not infringe upon Wyeth's listed patents, according to a company news release.

Wyeth markets Effexor XR for the treatment of depression. According to Wolters Kluwer Health, U.S. sales of Effexor XR Capsules were about $2.5 billion in the 12 months ended Jan. 31.

"We intend to vigorously defend our aNDA," Impax chief executive officer Barry R. Edwards said in the release.

"This suit is par for the course for branded pharmaceutical manufacturers attempting to keep patients from access to less expensive medications, even though their patents aren't applicable or will have expired."

Impax is a technology-based specialty pharmaceutical company based in Hayward, Calif.

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