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Donepezil 23 mg, or how to avoid the competition of the corresponding generics.

Author : Pierre Allain Date : 2012-4-21

In the U.S., donepezil, Aricept* is marketed as tablets of 5 and 10 mg and now 23 mg. Two American authors in a letter to the BMJ , March 22, 2012, tell how Eisai Laboratory obtained from the FDA, 4 months before the end of the patent, in fact four months before the possibility of making generics, the authorization to market a presentation of  23 mg (which cannot be obtained by combining 5 and 10 mg). The authors show that the FDA approved the 23 mg presentation although it has no documented superiority compared to the 10 mg presentation already marketed. The presentation 23 mg is largely sold in the United States in spite of the protests of consumer organisations who ask its withdrawal from the market.
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