Copaxone is marketed for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS).
Multiple sclerosis is a chronic disease of the central nervous system (CNS) characterized by inflammation and neurodegeneration.
RRMS, defined by inflammatory attacks on the protective coating of neurons (myelin) and characterized by intermittent bouts of symptoms, is the most common disease course at the time of diagnosis. Sandoz is the company’s development and commercialization partner for this product candidate.
If the ANDA is approved the company would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman.
The company expects to make the product available in the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines.
Since the 40mg/mL formulation contains the same drug substance as the 20mg/mL ANDA currently under review by the FDA, the company expects that the FDA review process can be completed within the same time frame.
Momenta Pharmaceuticals president and chief executive officer Craig Wheeler said the company is happy to announce the acceptance of the ANDA for its three-times-a-week generic Copaxone for review by the FDA.
"This formulation will allow for a more affordable, three-times-a-week dosing regimen for patients with relapsing-forms of multiple sclerosis," Wheeler said.