INTERNATIONAL PHARMACEUTICALS' VINCRISTINE MARKETING APPROVAL

Executive Summary

INTERNATIONAL PHARMACEUTICALS' VINCRISTINE MARKETING APPROVAL was reportedly rescinded by FDA Dec. 2. FDA approved an ANDA for International's vincristine sulfate injection in 1 mg/ml, in 1 ml, 2 ml, and 5 ml vials on Nov. 26. Two days later, on Nov. 28, the agency received a patent certification from Lilly for its liquid vincristine product, Oncovin. Lilly was granted a formulation patent by the Patent and Trademark Office on Oct. 28. Lilly says the formulation patent gives it exclusive right to "make, use and sell the patented liquid formulations of vincristine sulfate" for 17 years. Two other firms have received approval for generic versions of liquid injectable vincristine, Par's Quad subsidiary in April and LyphoMed in September. The Quad and LyphoMed approvals were issued before Lilly was granted a patent. A patent infringement suit against Quad was filed the same day Lilly was granted its patent ("The Pink Sheet" Nov. 3, T&G-2). LyphoMed, in turn, filed suit against Lilly seeking to have Lilly's patent declared invalid. Adria also markets the vincristine formulation under a licensing agreement with Quad.