By Arun Kumar, IANS,
Washington : The US Food and Drug Administration has asked a federal judge to throw out Mylan Inc’s lawsuit to clear the way for the company’s generic version of Lipitor and deny a rival bid by India’s Ranbaxy Laboratories.In a court filing this week, the FDA disputed claims Mylan made in a lawsuit filed last month in federal court in Washington to force the agency to allow it to introduce the generic version of Pfizer Inc’s cholesterol-lowering drug as early as June, the Wall Street Journal reported.
Mylan wants the FDA to deny an application by rival Ranbaxy Laboratories, the largest drug maker in India but majority owned by Japan’s Daiichi, to sell generic Lipitor, and to deny Ranbaxy a six-month period of market exclusivity for the copycat product, the Journal said.
Ranbaxy has been targeting a November launch of generic Lipitor under the terms of a 2008 agreement with Pfizer to resolve patent litigation.
Ranbaxy expects to get a six-month exclusivity period under federal law because it was the first to challenge US patents for Lipitor in 2002.
However, Mylan argues the FDA should block Ranbaxy’s Lipitor application because the agency in 2009 accused a Ranbaxy manufacturing plant in India of submitting false and unreliable data in its drug applications to the FDA, the Journal reported.
The agency has subjected the company’s drug applications to special scrutiny in light of the allegations. Ranbaxy has disputed the FDA’s allegations but has cooperated with the agency to resolve the issues.
Mylan wants the FDA to clear the way for Mylan to launch its own generic Lipitor in late June, when certain patent protection associated with Lipitor expires, the Journal reported.
Mylan has asked a judge to order an injunction compelling FDA to take action immediately.
But the FDA said in an April 4 court filing it was premature for Mylan to seek such court action because the agency hasn’t yet granted tentative approval of any application for generic Lipitor, including Ranbaxy’s and Mylan’s.
The FDA said it’s still considering the applications, and it can’t decide on any exclusivity until an application is ready for approval and a final exclusivity decision “may or may not” come before June 28.
The FDA also said in its court filing it’s “engaged in ongoing and confidential discussions with Ranbaxy to resolve the issues” raised by the agency in 2009.
Ranbaxy also has filed a court document opposing Mylan’s efforts. Ranbaxy said in the filing it has “fought hard” for the right to 180 days of marketing exclusivity for generic Lipitor.
According to the FDA court filing, Mylan claims the uncertainty surrounding the FDA’s decision on Ranbaxy has forced Mylan to lower its market-share target for generic Lipitor to 20 percent from 40 percent.
(Arun Kumar can be contacted at [email protected])