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news.The FDA has granted tentative approval for Teva Pharmaceutical's abbreviated new drug application to market donepezil hydrochloride 5mg and 10mg for Alzheimer's treatment.
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Donepezil hydrochloride is a generic version of Eisai’s Aricept tablets and the brand product had annual sales of approximately $1.6 billion in the US for the 12 months ended September 30, 2007, based on IMS sales data.
Teva is currently in patent litigation concerning this product in the US District Court. Although a trial date has not been set, the court has set a briefing schedule for a preliminary injunction motion under which Eisai must file its request no later than February 15, 2008. Final approval of this abbreviated new drug application (ANDA) is anticipated on or about April 26, 2008, upon expiry of the mandatory stay of approval associated with the patent litigation.