Ranbaxy wins 180-day exclusivity for simvastatin
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.
By TNN |
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 district court’s decision, Ranbaxy launched 80mg tablets with six-month exclusivity in June.It currently has over 60% market share for the 80 mg simvastatin tablets.
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 district court’s decision, Ranbaxy launched 80mg tablets with six-month exclusivity in June.It currently has over 60% market share for the 80 mg simvastatin tablets.
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