Sun Pharmaceutical Industries Ltd 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, US FDA 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 US 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.