The Hindu Business Line : Cholesterol drug: Ranbaxy wins at US appeals court

Unlike the Lipitor case where Ranbaxy Laboratories Ltd has been facing severe legal hurdles, a US Court of Appeal has upheld a district court's ruling granting Ranbaxy a 180-day exclusivity on the 80 mg strength of the anti-cholesterol drug, Simvastatin (the generic form of Merck's blockbuster drug, Zocor).

"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 US healthcare system,'' said Mr Jay Deshmukh, Senior Vice-President of Global Intellectual Property, Ranbaxy.

The US Court of Appeals for the District of Columbia Circuit reaffirmed an earlier order by a District Court on Simvastatin, which had directed the Food and Drug Administration (FDA) to allow Ranbaxy to launch the generic versions of Zocor in June and retain an exclusivity period of 180 days along with Israel's Teva Pharmaceuticals, as both companies had first-to-file status with the FDA across dosage forms.

Zocor's sales had diminished after the expiry. However, because Merck had delisted the patents before the expiry, the FDA had prohibited any company from obtaining a six-month exclusivity period generic Zocor.

Teva and Ranbaxy took the FDA to federal court and in April had won a ruling for a 180-day period of exclusivity. FDA made an appeal against the ruling, resulting in Tuesday's ruling where the US Court of Appeals upheld the district court's verdict. The market size for the 80 mg dosage form was estimated annually at about $500 million (Rs 2,250 crore) as of March this year; post the Merck's patent demise. Since the launch of Simvastatin in June, Ranbaxy has cornered close to 60 per cent of this market.

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