Mumbai: Sun Pharmaceutical Industries Ltd. today announced a settlement agreement with Novartis stipulating a dismissal of the lawsuits filed in the United States against the Indian company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Exelon, rivastigmine tartrate capsules.
Earlier in October this year, the US FDA had granted final approval for the Sun Pharmaceutical''s ANDA to market its generic Exelon. (See: US FDA approves Sun Pharmaceutical''''s Novartis-equivalent generic Exelon capsules for US markets)
Under the terms of the settlement agreement, Sun Pharma will not market generic Exelon in the US until some time prior to the expiration of the patents covering Exelon. The specific date on which Sun may launch and the other terms of the agreement remain confidential.
Exelon, a registered trademark of Novartis''s rivastigmine tartrate caspsules for oral use, is indicated in the treatment of mild to moderate dementia of the Alzheimer''''s type and for the treatment of mild to moderate dementia associated with Parkinson''''s disease.
While the precise mechanism of rivastigmine''''s action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function.