Drug: Aricept (donepezil HCl)
Indication: Alzheimer's-related dementia
Expiration Date: Nov. 25
Scoop: A number of drugmakers are trying to get FDA approval for their generic versions of Eisai and Pfizer's Aricept--a treatment for Alzheimer's-related dementia that brings in $3 billion annually. Mutual Pharmaceutical won approval for its 5mg and 10mg orally disintegrating tablets in December. URL Pharma, Mutual's parent company, plans to market donepezil after the Nov. 25 expiration of the '841 patent.
Roxane, Apotex and Aurobindo all have submitted ANDAs for multiple strengths of the drug, as does Teva, which won tentative approval in early 2008. However, Teva was enjoined from selling its product by a district court the same year.
Eisai has promised to make up for Aricept's loss. "To make our revenue flow steady in 2010 and beyond, we are keeping up efforts" to minimize the impact of Aricept's U.S. patent expiry in November by launching new drugs, Eisai President Haruo Naito said in a recent news conference, according to the Wall Street Journal.