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Mumbai, Feb 7: It’s high time for the Indian pharmaceutical firms to show their mettle in fighting the world’s leading generic players to get a pie of the largest selling drugs in the US, which are going off patent this year. Though the Indian firms have already been given tentative approvals by the US FDA for a few of the blockbuster molecules, the innovator company’s strategy to give authorised generic rights to other firms hamper the Indian firms chances. About 11 leading drugs, including four blockbuster drugs worth $20 billion are going off-patent this year in the US.
Merck’s osteoporosis drug, Fosamax, will be a major revenue earner for the generic players like Teva, Barr, which have launched the drug with 180-day exclusivity. Sensing the threat, Merck has already signed an agreement with Watson Pharma giving rights to sell authorised generics across the US.
Interestingly, no Indian company is learnt to have been given approval by the US FDA. Fosamax has sales of $1.6 billion in the US.
Varun Chonker, an intellectual property expert, said, “Although there are a number of drugs going off-patent in 2008 including a few blockbusters, it would be interesting to observe how Indian companies consolidate this generic opportunity, particularly when dollar depreciation is likely to hit their profit margins, which may further erode by intense generic competition in the US.” Pharmaceutical consultancy IMS Health says that, in all, by 2011 drugs worth some $60 billion will come off patent. Zydus Pharma, Wockhardt and Ranbaxy are ready to launch Depakote, the psychiatric drug from Abbott, which registered sales of $421 million only for the last quarter. Dabur has received tentative approval for Camptosar, a $959-million drug for cancer from Pfizer.
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