Biovail Files Suit Against Impax Over Generic Wellbutrin

Biovail Laboratories has filed a lawsuit in federal court against generic firm Impax over its bid to launch a generic version of Biovail's Wellbutrin XL, an antidepressant marketed by GlaxoSmithKline.

The lawsuit, filed in the U.S. District Court for the Eastern District of Pennsylvania, alleges that Impax's abbreviated new drug application (ANDA) for generic Wellbutrin XL (bupropion HCl) in 150- and 300-mg extended-release tablets infringes on Biovail's listed patent for the drug. The patent in question, U.S. Patent No. 6,096,341, will not expire until Oct. 30, 2018, according to the FDA's Orange Book.

Biovail is requesting relief from the court in the form of a judgment stating that Impax has infringed the patent, as well as a court order that the FDA cannot approve ANDAs for any generic versions of Wellbutrin XL prior to the 2018 patent expiry date. Wellbutrin XL tablets had total U.S. sales of approximately $1 billion in 2004, according to NDCHealth data.