In two different cases before the US District Court for the Middle District of North Carolina Apotex has alleged that Ranbaxy's inability to launch its generic versions of donepezil hydrochloride (sold by Eisai Co. under the brand Aricept®) and valacyclovir hydrochloride (sold by GSK under the brand Valtrex®) on time will injure Apotex. Ranbaxy was the first generic company to file for permission to market the generic versions of Aricept and Valtrex in the United States. As such it is entitled to a 180-day exclusivity period before other generics, including Apotex, can bring their versions of the drugs to market. Because it is now uncertain when Ranbaxy will be able to obtain approval for the two products from the USFDA, Apotex claims that it cannot properly plan the launch of its own products. If Apotex is successful, Ranbaxy's 180-day exclusivity period for the drugs will begin immediately, regardless of whether or not Ranbaxy can actually market the drug (due to USFDA constraints).
For more information, please see: http://www.reuters.com/article/rbssHealthcareNews/idUSN0743246020090707 or http://www.myiris.com/newsCentre/newsPopup.php?fileR=20090709143220707&dir=2009/07/09&secID=livenews