Dr Reddy's Laboratories Ltd today announced that the company has entered into a settlement agreement with Novartis Pharma AG, which involves a stipulation of dismissal of the lawsuits in the United States relating to the abbreviated new drug applications filed by Dr Reddy's for a generic version of rivastigmine tartrate capsules sold under the trade-name Exelon.
Under the terms of the agreement, Dr Reddy's will not launch its generic Rivastigmine Tartrate capsules until some time before the expiry of the Orange Book patents claiming Rivastigmine. The exact date of launch and other terms of this agreement are confidential.
In October 2007, the company received the final approval from US FDA on its ANDA for Rivastigmine capsules.
Rivastigmine tartrate capsules is the generic version of the Novartis' product Exelon indicated for the treatment of mild-to-moderate Alzheimer's disease dementia. As per the IMS June 2007 moving annual total, the annual sales of this product in the US were $199 million.