Dr Reddy's gets USFDA nod for Allegra generic
Dr Reddy's Laboratories has received the US Food and Drug Administration's approval to launch the generic version of Sanofi-Aventis' allergy drug Allegra, reports CNBC-TV18's Ekta Batra.
Dr Reddy's has received final clearance from the USFDA nod for Sanofi Aventis’s drug Allegra D24. The company seems to be the only filer for the drug. It also has first to file rights when the patent for Allegra D24 expires in 2012.
India's second-largest drugmaker by sales plans to launch the drug at risk in US by Q1 FY11. At risk launch will make it a multi-year opportunity. The drug has a market size of USD 180 million in the US.
DRL is likely to get USD 55 million from Allegra D24 generic sales in FY11. An at-risk launch is earnings per share (EPS) accretive by Rs 9 and Rs 5 for FY11 and FY12.
When contacted, the company said it plans to launch Alegra D12 and D24 in FY11. "We are looking to launch Alegra D24 within the next 30 to 45 days." DRL is likely to clock in USD 200 million in sales from Alegra D24 in three years.
DRL said it expects a second generic player for Alegra D12. "We expect limited competition opportunities for Fondaphrinux." Fondaphrinux has sales of USD 200 million.
March 22, 2010