Indian-based Sun Pharmaceutical Industries announced on 29 September 2010 that the FDA had granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceuticals’ (a part of AstraZeneca) anti-cholesterol drug Crestor (rosuvastatin calcium).
Sun gains tentative approval for generic Crestor
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Posted 21/01/2011
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These generic rosuvastatin tablets contain rosuvastatin calcium 5 mg, 10 mg, 20 mg, 40 mg.
Generic rosuvastatin calcium tablets are indicated in patients with hypertriglyceridemia as an adjunct to diet and patients with homozygous familial hypercholesterolemia.
Crestor has US annual sales of approximately US$3.4 billion.
The tentative approval, however, means that Sun cannot sell the generic version of Crestor in the US, yet. Back in June 2010, AstraZeneca, who hold the patents on Crestor, won a court battle to stop several generic manufacturers from marketing rosuvastatin in the US after a whopping nine manufacturers submitted ANDAs in 2007. The patents that support Crestor will start expiring in 2016.
This means that the generics companies will now have to wait until 2016 to gain another piece of the huge statin pie, unless a generic-licensing agreement comes along sooner.
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Source: Sun Pharmaceuticals
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