BIOVAIL FILES LAWSUIT AGAINST ANDRX

Biovail Laboratories has filed a lawsuit against Andrx Pharmaceuticals, alleging that Andrx's planned generic version of hypertension treatment Cardizem LA infringes Biovail's patent on the drug.

Andrx filed an abbreviated new drug application (ANDA) with the FDA this summer stating its intention to develop and market its own version of Cardizem LA (diltiazem HCl). As required by the Hatch-Waxman Act, Andrx informed Biovail of its ANDA in June, prompting Biovail's complaint. Biovail filed the lawsuit in the U.S. District Court for the District of Delaware.

Biovail is seeking a permanent injunction to prevent Andrx from creating its proposed drug tablet containing compressed coated beads, which will systematically release the drug's compounds using specific wetting agents. Biovail contends its '791 covers the extended release function of Cardizem LA. The patent isn't scheduled to expire until June 25, 2013, according to the FDA's Orange Book.