Lupin recieves USFDA approval for hypertension generic

26 March 2013 | News | By BioSpectrum Bureau

Pharma major, Lupin announced that its subsidiary Lupin Pharmaceuticals has received final approval for its Valsartan and Hydrochlorothiazide Tablets USP from the United States Food and Drugs Administration (USFDA) to market a generic version of Novartis' Diovan HCT Tablets. Lupin has already commenced shipping the product. Headquartered in Baltimore, Lupin Pharmaceuticals is the wholly owned U.S. subsidiary of Lupin Limited.

Lupin's Valsartan and Hydrochlorothiazide Tablets USP is indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

According to IMS MAT Sept 2012 sales, Valsartan and Hydrochlorothiazide Tablets had annual U.S sales of approximately USD 1.7 billion. Lupin is currently the 5th largest generics company in the US market (by prescriptions), and has received 6 approvals in the last two months, seems to be in line to launch around 10 products for the current fiscal. The US contributed 42 % of Lupin's consolidated revenues for the third quarter of the current year and reported growth of 68 % for the US Market. The company has revenues of USD 506 million in revenues.

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