Teva Announces Tentative Approval Of Generic Aricept(R) Tablets

Main Category: Alzheimer's / Dementia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Jan 2008 - 1:00 PDT

email to a friend   printer friendly   opinions  

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Eisai's Alzheimer's treatment Aricept® (Donepezil Hydrochloride) Tablets, 5 mg and 10 mg. The brand product had annual sales of approximately $1.6 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of New Jersey involving Teva's paragraph IV certification to U.S. Patent No. 4,895,841. 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 ANDA is anticipated on or about April 26, 2008, upon expiry of the mandatory stay of approval associated with the patent litigation.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe.

Teva Pharmaceutical Industries Ltd.

• Additional
• References
• Citations