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.
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Ranbaxy challenged the decision on the basis that it was inconsistent with the Hatch-Waxman Act. Following the …
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