Ranbaxy Laboratories has run up against regulatory troubles yet again. The company was supposed to be set for a March 2 launch of generic Flomax, the Astellas Pharma urology drug. As first to file for FDA approval, Ranbaxy has that coveted exclusivity period, when generics are the most profitable they'll ever be. But the FDA didn't okay the drug in time.
It's the second time that Ranbaxy lost out on its first-to-launch opportunity, the Wall Street Journal reports; last year, the company couldn't debut its version of the GlaxoSmithKline migraine remedy Imitrex on time, also because of a delay in getting FDA approval. And the Flomax fiasco comes at a time when Ranbaxy's sales are still suffering because of manufacturing problems that prompted an outright ban on imports of 30 of its drugs back in the fall of 2008.
On Flomax, Ranbaxy had come to a patent settlement with Astellas that would allow it to start selling its version of the drug yesterday; it would have eight weeks of exclusive sales. Instead, rival Impax Laboratories, which had also settled a patent dispute with Astellas, got to be first to launch.