Washington, May 3: A US judge has dismissed a rival drug company’s attempt to block India’s Ranbaxy from launching a generic version of Pfizer Inc’s popular cholesterol-lowering drug Lipitor on an exclive basis for six months.
Ranbaxy is expected to launch its generic Lipitor Nov 30 under a settlement deal with Pfizer that gives it the right to sell the drug on an exclusive basis for six months as the first company to apply for the cheaper version.
But rival Mylan sued the US Food and Drug Administration in March, accusing the agency of unreasonably delaying a decision on Ranbaxy Laboratories’ claim to exclusivity.
Mylan wanted US District Court Judge James Boasberg in Washington to force the FDA to make that decision now.
The company said that in the event Ranbaxy isn’t entitled to any exclusivity, other drug makers needed to know that information immediately in order to prepare for their own potential launch of generic Lipitor later this year.
Boasberg instead threw out the case, ruling that Mylan’s lawsuit was premature. The judge said the company had no legal standing to bring the lawsuit because it wasn’t suffering an immediate injury.
He noted that Mylan wasn’t the first to file an application to market generic Lipitor and hasn’t received tentative FDA approval of its application.
The FDA said in court papers that resolving the exclusivity rights for generic Lipitor was not a straightforward matter, and said it would reach a decision ‘as soon as practicable.’
(Arun Kumar can be contacted at firstname.lastname@example.org)