The patent on the ethical version of the Parkinson's drug will expire in May 2008.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of GlaxoSmithKline's Requip (Ropinirole HCl) tablets, at dosages ranging from 0.25 mg base to 5 mg base. Final approval of Teva’s generic version of Ropinirole is expected upon expiry of patent protection for the brand product on May 19, 2008.
Upon final approval, Teva’s product will be the AB-rated generic equivalent of Requip tablets, and will be indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease as well as treatment of moderate to severe primary restless leg syndrome.
The brand product had annual sales of approximately $455 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Teva's share closed up 0.63% at $44.63 on Friday on Nasdaq, giving the company a market cap of $34.1 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on December 2, 2007
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