Lupin Pharmaceuticals Inc. has received final approval for its Valsartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Novartis Pharmaceuticals Corp.’s (Novartis) Diovan HCT® Tablets, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg, respectively. Lupin has already commenced shipping the product.
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.
Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg had annual U.S sales of approximately USD 1.7 billion (IMS MAT Sept 2012 sales).
About Lupin Limited
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
For the financial year ended March 2012, Lupins Consolidated Total Income and Profit after Tax were Rs. 70,972 million (USD 1.49 billion) and Rs.8,676 million (USD 182 million) respectively. Please visit http://www.lupinworld.com for more information.
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com
For further information please contact: