Ranbaxy's generic tamsulosin is delayed

Ranbaxy Laboratories’ stab at potential sales of millions of dollars has come to naught after it failed to secure the FDA’s permission to market the generic version of tamsulosin (Flomax) in the US. Ranbaxy, the Indian unit of Japanese drugmaker Daiichi Sankyo, was to launch the generic version of the Japan-based Astellas’ Flomax on March 2, 2010 in the US, eight weeks before the drug’s patent expires in the US following an out-of-court settlement in 2007. Flomax, used to treat prostrate enlargement and marketed by German drugmaker Boehringer Ingelheim, recorded sales of around $2 billion in the US last year. 

The USFDA refusal to give permission is another blow for the Gurgaon-based drugmaker, whose 30 drugs were banned by the FDA in September 2008. The FDA also halted fresh approval for two of its Indian plants for violating US manufacturing rules. Early last year, the FDA also delayed the launch of its generic version of GlaxoSmithKline’s Imitrex. The spokesman did not set a new launch date. Even if Ranbaxy is able to launch the product, its upside will be severely limited as it enjoyed only an eight-week marketing exclusivity window. 

Moreover, US-based Impax Laboratories, another generic drug maker, was able to launch its product on Tuesday.  Impax had also arrived at an out-of-court settlement with Astellas over the drug. An Impax release quoting a Wolters Kluwer Health figure said Flomax saw sales of around $1.9 billion for the 12 months ended August 31, 2009, in the US. A back-of-the-envelope calculation suggests that Ranbaxy could have earned up to $100 million during the eight-week exclusivity period. Ranbaxy would have been one of only three companies selling the drug besides Impax and Boehringer Ingelheim during that period. Once the patent of an original drug expires, several drugmakers launch their low-cost versions and there is significant price erosion, sometimes up to 95%. But during the period of marketing exclusivity, there are few players and price erosion is considerably less. 

AstraZeneca sues Lupin on Nexium IV generic

AstraZeneca sued India’s Sun Pharmaceuticals Industries Ltd. to prevent it from selling a generic form of the ulcer medicine Nexium IV in the U.S. before 2014. Sun is seeking U.S. Food and Drug Administration approval to sell Nexium in a form that is delivered through intravenous injections. AstraZeneca claims the generic copy would infringe two patents that expire in May 2014 and November 2014. Nexium IV, first approved by regulators in 2005, is similar to the “purple pill” that is most commonly sold as a capsule. Nexium in all forms generated $2.84 billion in U.S. sales last year for the London-based company, AstraZeneca said Jan. 28. Global Nexium sales were $4.96 billion, making it AstraZeneca’s biggest seller. Nexium IV is a small part of sales and is typically given while people are in the hospital through an intravenous drip, said Blair Hains, a spokesman for the company. He said the company doesn’t break out sales of Nexium IV. AstraZeneca settled patent claims against Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd., with both agreeing not to sell the Nexium pill until 2014. Similar suits are still pending against Lupin Ltd. and Dr. Reddy’s Laboratories Ltd., AstraZeneca said.