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.