Ranbaxy wins 180-day exclusivity for simvastatin.
Economic Times (New Delhi, India), November, 2006
Nov. 16--NEW DELHI -- The US Court of Appeals has upheld the 180-day exclusivity of Ranbaxy's cholesterol-lowering drug simvastatin, reports Our Bureau. It has affirmed a similar verdict given by a district circuit earlier.
Merck, the patent holder of the $6-bn cholesterol-lowering drug, had delisted two patents on its branded drug over a year ago, which the FDA interpreted as eliminating Ranbaxy's six-month exclusivity on the 80mg strength of Simvastatin tablets.
Ranbaxy challenged the decision on the basis that it was inconsistent with the Hatch-Waxman Act. Following the ...
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