Thursday, December 6, 2007

Sun Pharma Announces Settlement of Litigation Over Generic Exelon

MUMBAI, India, Dec. 6, 2007-Sun Pharmaceutical Industries Ltd. announced that it has executed a settlement agreement with Novartis stipulating a dismissal of the lawsuits filed in the United States against the Company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Exelon, rivastigmine tartrate capsules.

Earlier, USFDA had granted final approval for the Company's ANDA to market its generic Exelon®.

Under the terms of the settlement agreement, Sun Pharma will not market generic Exelon® in the U.S. until sometime prior to the expiration of the patents covering Exelon®. The specific date on which Sun may launch and the other terms of the agreement are confidential.

No comments: