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news.The FDA has granted Teva Pharmaceutical approval to market its generic version of Procter and Gamble's Actonel tablets, 5mg, 30mg and 35mg for the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget's disease.
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Teva is currently in patent litigation concerning this product in the US district court for the District of Delaware. In connection with the pending patent litigation, Teva has agreed to provide 30 days advance notice to Procter & Gamble of any launch activities and has not yet provided such notice.
As the first company to file an abbreviated new drug application with a paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product, which will begin to run from the date of commercial marketing.