Lupin gets FDA nod for generic version of Suprep

Malini BhuptaMoneycontrol NewsIndia’s second largest pharmaceutical major Lupin announced on Tuesday that the US Food and Drug Administration had granted it approval to market the generic version of Braintree Laboratories’ Suprep Bowel Prep Kit. Suprep follows a split dose regime and Lupin has got approval for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, all of which are taken to cleanse the colon before colonoscopy in adults. Suprep Bowel Prep Kit has a market of USD 207 million in the USA.Analysts believe this is positive for Lupin as the company will launch the generic version under a 180-day exclusivity period. The Indian pharma major is expected to generate sales of USD 30 million through this product launch. The Street is assuming a 30 percent price erosion and a market share of 20 percent for Lupin during the exclusivity period.The launch of this product will further give visibility to Lupin’s earnings and analysts are factoring in earnings per share of Rs 1.5 thanks to this launch. Lupin is expected to have a limited competition in this product as well post the exclusivity period.