Ranbaxy Granted favorable decision by the U.S. Court of Appeals regarding marketing exclusivity for Simvastatin 80mg

Ranbaxy Laboratories Ltd on November 15, 2006 has announced that the U.S. Court of Appeals for the District of Columbia Circuit has affirmed an earlier District Circuit holding on Simvastatin, preserving 180-day exclusivity when patents are delisted from the FDA Orange Book.

Earlier, Merck & Co., Inc. had delisted two patents on its branded drug, Zocor® (simvastatin), which the FDA interpreted as eliminating the Company's 180-day exclusivity on the 80 mg strength of Simvastatin tablets. The Company challenged this decision on the basis that it was inconsistent with the Hatch-Waxman Act. The Generic Pharmaceutical Association (GPhA) filed an amicus brief supporting the Company's position. The District Court agreed and the Company launched 80 mg Simvastatin tablets with 180-day exclusivity in June 2006. The Company currently has over 60 percent market share for the 80 mg strength of Simvastatin tablets.

Commenting on the decision, Jay Deshmukh, Senior Vice President - Global Intellectual Property, of the Company, noted, "We are pleased with this decision, for both Ranbaxy and the generic pharmaceutical industry, as it preserves the exclusivity of innovative generic pharmaceutical Companies who expend significant effort and finances to introduce affordable generic medicines to the U.S. healthcare system."

Source : Equity Bulls

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