Ranbaxy Misses Out on U.S. Launch of Generic Flomax

04/03/2010 09:50
Ranbaxy Laboratories Ltd. said Wednesday it couldn't launch a air jordan shoesgeneric drug to treat urinary disorders as planned in the U.S. because of not getting the Food and Drug Administration's clearances on time,Nike Shox Shoes highlighting the difficulties the Indian company is facing to sort out regulatory issues in its biggest market. This is the second time that Ranbaxy, which is embroiled in regulatory issues in the U.S., lost out on launching its products on time to benefit from an exclusivity period given to companies filing first to Nike Air Max Shoessell generic versions of patented drugs. The exclusivity period typically generates higher revenue and better margins. Ranbaxy--India's biggest drug maker by sales and a unit of Japan's Daiichi Sankyo Co.--had the "first-to-file" status on the generic version of Flomax. Japan's Astellas Pharma Inc. holds the patent onAir Max the urinary-disorder drug, while Germany's Boehringer Ingelheim GmbH markets it in the U.S. The company had last year lost out on being the Air Max shoesfirst to launch a generic version of GlaxoSmithKline PLC.'s migraine drug, Imitrex, in the U.S., also because of a delay in receiving FDA's approval. Under a patent settlement agreement with Nike Basketball ShoesAstellas on Flomax--also known by its generic name tamsulosin hydrochloride--the Indian company was to launch the drug in the U.S. on March 2 and it would have enjoyed eight weeks of exclusive sales for the drug. "We regret that, despite our best efforts, we were not able toair force 1 High get an approval for the subject product, and hence will not be in a position to launch the product," a spokesman for Ranbaxy said in an emailed statement. Aarthisundari Jayakumar, a pharma analyst at Alchemy Share & Stock Brokers Pvt. Ltd., said she was estimating sales of about $60 million for the company in the eight-week exclusivity period, which, she said, would have translated into earnings of 4 rupees ($0.08)-5 rupees per share. Meanwhile, U.S.-based Impax Laboratories Inc., which had also settled a patent lawsuit with Astellas Pharma and Boehringer, launched the drug Tuesday. Total sales of Flomax were about $2.1 billion in 2009, according to Wolters Kluwer Health.Allen Iverson Shoes Other NBA Star Shoes Dirk Nowitzki Shoes Steve Nash Shoes Nike air force 1 High Nike air force 1 Low Nike air force 1 Low 07