The most popular question among the analysts and trade specialists today is" Will Ranbaxy sell its Lipitor rights?"
After winning the rights for 180 day exclusivity of Lipitor in U.S(2008), Ranbaxy was considered to be sitting on a cake of profits. Although citing regulatory reasons, FDA withdrew its approval of several manufacturing plants of Ranbaxy, leading to wide speculations about the status of Lipitor. The generic copy of Lipitor was slated to be released on Nov.30, 2011, over which clouds of doubt reside!!
Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. An FDA investigation into quality standards at two Ranbaxy manufacturing plants and a federal investigation into its testing practices have delayed approval of the drug copy. Federal prosecutors are negotiating a dispute settlement that may cost Ranbaxy more than $1 billion, Fortune Magazine reported in May.
If Ranbaxy doesn't get approval by Nov. 30, it may postpone the release of its copycat Lipitor.This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.Mylan, actually tried to force FDA to nullify Ranbaxy's exclusive rights, given the company's difficulty obtaining approval, but a judge tossed out that lawsuit.
Alternativley, If the delay is lengthy, than Ranbaxy has got a chance to waive the exclusivity in return for payment from another drugmaker, either a lump sum or a piece of the sales,as reported by Bloomberg.
Ranbaxy, 64-percent owned by Tokyo-based Daiichi Sankyo Co., received a one-time payment from Boehringer Ingelheim GmbH last year for relinquishing its 180-day exclusivity on the Flomax prostate treatment under similar circumstances.
The officials at Daichi Sankyo refused to comment on the pending approval of lipitor by FDA. It remains to be seen which path Ranbaxy takes to come out of this situation. Till then, the markets would be abuzz with the question...."Will Ranbaxy sell its Lipitor rights?"
Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. An FDA investigation into quality standards at two Ranbaxy manufacturing plants and a federal investigation into its testing practices have delayed approval of the drug copy. Federal prosecutors are negotiating a dispute settlement that may cost Ranbaxy more than $1 billion, Fortune Magazine reported in May.
If Ranbaxy doesn't get approval by Nov. 30, it may postpone the release of its copycat Lipitor.This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.Mylan, actually tried to force FDA to nullify Ranbaxy's exclusive rights, given the company's difficulty obtaining approval, but a judge tossed out that lawsuit.
Alternativley, If the delay is lengthy, than Ranbaxy has got a chance to waive the exclusivity in return for payment from another drugmaker, either a lump sum or a piece of the sales,as reported by Bloomberg.
Ranbaxy, 64-percent owned by Tokyo-based Daiichi Sankyo Co., received a one-time payment from Boehringer Ingelheim GmbH last year for relinquishing its 180-day exclusivity on the Flomax prostate treatment under similar circumstances.
The officials at Daichi Sankyo refused to comment on the pending approval of lipitor by FDA. It remains to be seen which path Ranbaxy takes to come out of this situation. Till then, the markets would be abuzz with the question...."Will Ranbaxy sell its Lipitor rights?"
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