FDAnews
www.fdanews.com/articles/61442-japan-s-eisai-sues-u-s-firm-over-aricept

JAPAN'S EISAI SUES U.S. FIRM OVER ARICEPT

August 4, 2006

Japanese drugmaker Eisai has filed a lawsuit against United Research Laboratories and Mutual Pharmaceutical regarding the submission of an abbreviated new drug application to the FDA for Aricept Orally Disintegrating Tablets (donepezil HCl). Eisai's action was filed in the U.S. District Court for the District of New Jersey on Aug. 3.

Eisai says that its patent for the composition of donepezil is valid until its expiration date of Nov. 25, 2010. The company intends to defend the patent.

Aricept is indicated for the treatment of Alzheimer's disease. The drug is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain.