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news.Biovail Corporation subsidiary Biovail Laboratories has commenced a legal action in its own name, and in the name of SmithKline Beecham Corporation, against two companies that have filed abbreviated new drug applications with the FDA for generic versions of Biovail's antidepressant Wellbutrin XL.
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The formulation for Wellbutrin XL (bupropion hydrochloride extended-release tablets) was developed by Biovail, which licensed the product’s worldwide (excluding Canada) sales and distribution rights to GlaxoSmithKline in October 2001. The drug is indicated for the treatment of major depressive disorder in patients aged 18 and older.
Biovail filed suit in the US District Court for the Central District of California against Anchen Pharmaceuticals, which has submitted an abbreviated new drug applications (ANDA) for generic 150mg and 300mg versions of Wellbutrin XL.
Biovail also filed suit in the US District Court for the Southern District of Florida against Abrika Pharmaceuticals, which has submitted an ANDA for a generic 150mg version of Wellbutrin XL.
The patent estate protecting Wellbutrin XL consists of two formulation patents listed in the FDA’s approved drug products with therapeutic equivalence evaluations database, commonly referred to as the Orange Book. These two formulation patents expire in 2018.