Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained final US Food and Drug Administration (FDA) approval for its generic version of Actonel, made by Proctor & Gamble Inc. (NYSE:PG) for the treatment of osteoporosis.
Teva is in litigation with Proctor & Gamble over the drug. The US District Court for the District of Delaware heard the case in November 2006, but no judgement has been handed down yet. In connection with the pending patent litigation, Teva agreed to provide 30 days advance notice to Procter & Gamble of any launch activities, and it has not yet done so.
Teva's AB-rated Risedronate Sodium tablets treat and prevent postmenopausal and glucocorticoid-induced osteoporosis, and treat Paget's disease. According to IMS sales data, brand Actonel had $1 billion in US sales in the twelve months through June.
As the first company to file an Abbreviated New Drug Application (ANDA) with a Paragraph IV patent certification for generic Actonel, Teva has 180 days marketing exclusivity for this product.
Teva rose 0.5% to $44 by midday on Nasdaq, and rose 1.1% on the TASE today. It has a market cap of $33.6 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on October 8, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
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