Aricept (donepezil hydrochloride), Eisai Pharmaceutical’s biggest selling drug, comes off patent in the US in November 2010. Thereafter donepezil hydrochloride may be sold as a generic drug. Teva has applied to sell donepezil, but the FDA granted Ranbaxy first access to the lucrative market in a letter dated 17 September 2010.
Ranbaxy beats Teva to Alzheimer’s drug
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Posted 26/11/2010
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Eisai Pharmaceutical is reported to have made Euros 2.3 billion from Aricept in the last financial year, the majority of that from the US market. Ranbaxy will now have exclusive rights to market the generic version in the US for six months, after which it will face other generic competition.
An application by Teva to sell the treatment was changed from “approved” to “tentatively approved” effective immediately, precluding it from competing with Ranbaxy in the six-month period, the FDA said. The India-based Ranbaxy (64% owned by Daiichi-Sankyo) will need final permission from the regulator before marketing the drug. Neither company wished to comment on the situation.
Indian companies have so far achieved about 15% share of the US generics market, up from 13% in mid-2009. The generics market is expected to increase further as more drugs come off patent and the Obama administration seeks to reduce healthcare costs.
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