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Low cost Alzheimer drug by Ranbaxy to be in the U.S. market soon
By siliconindia
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Tuesday, 30 November 2010, 00:35 IST
New Delhi: With the final approval of the American Drug Regulator, a low cost version of Alzheimer?s drug Aricept will be launched in the US this week by Ranbaxy Laboratories which would help generate revenue of almost $200 million. The patent for Donepezil Hydrochloride sold under the brand Aricept by Japanese drugmaker Eisai expired on November 25.
Although Ranbaxy has declined to comment, a Mumbai based Pharma analyst on an anonymous condition had quoted that Ranbaxy expects to launch the drug in the next 2-3 days.
The estimate of Ranbaxy's potential gain from the low cost version of the drug varies from $200-300 million. Ranjit Kapadia, VP (Institutional Research) at HDFC Securities said the company could earn about $250 million. "All will depend on the pricing strategy of Ranbaxy and the authorized generic," he said.
If not for Eesai allowing the US based Greenstone, which makes low cost medicines for Pfizer to launch an authorized generic of Aricept, Ranbaxy could have profited more from the launch of the Alzheimer's drug. This has resulted in Ranbaxy to compete with another low priced product and in turn has decreased its revenue earning potential.
Aricept has annual global sales of about $3.2 billion, 60% of which comes from the US, the world's largest drug market. Ranbaxy had got tentative approval to launch Donepezil Hydrochloride tablets from US Food & Drug Administration (FDA) that had rejected Israel's Teva Pharmaceutical's claim for a joint exclusivity with Ranbaxy in September.
In March, Ranbaxy had failed to attain FDA's approval so as to launch its generic version of Flomax in the US although it received $50 million as settlement from Boehringer Ingelheim. Ranbaxy is currently trying to settle the two years old regulatory problems with FDA as FDA had banned 30 drugs made at its Indian plants and also stopped the approval of new drugs for the violation of US drug manufacturing norms.