Teva wins approval for generic Actonel

Teva is still in litigation with Proctor & Gamble over the osteoporosis treatment.

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 - - on October 8, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

View comments in rows
Update by email about comments talkback
Your name
Please insert your name
Hyperlink in a new window Hyperlink Right Left underline italic bold Bulleted List Ordered List Face1 Face2 Face3 Face4 Face5 Face6
Your comment

You comment was recieved and soon will be published.
In posting comments, I agree to abide by the Terms of Use
Globes encourages lively and frank debate, but posts that the editors consider merely abusive or otherwise inappropriate will be removed. Report inappropriate content
Thank you for posting your comment, which will be reviewed for publication.
Loading Comments...load
Load more comments
Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2016