Novartis has sued Lupin and Torrent Pharmaceuticals in district court regarding the filing of ANDAs with the US FDA, as the generics firms seek to bring to market their versions of the antihypertensive Exforge HCT (a combination of valsartan, amlodipine and hydrochlorothiazide) before patent expiry of US patents covering the product.
Exforge HCT received US approval in 2009 and was launched that year, as the first triple combination product for hypertension.