NATCO Pharma to sell multiple sclerosis drug in USA via Mylan

NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system.

The drug, Glatiramer Acetate, will be manufactured by NATCO and sold by Mylan, and are the AB rated equivalent of Teva’s Copaxone.

AB rated alternatives can be substituted by the pharmacist in place of the branded version, while non-AB rated alternatives can only be suggested by the doctor.

“Copaxone is the most prescribed MS treatment for relapsing forms of MS in the United States with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017,” the Indian company said.

Both dosages have been approved for sale by Mylan.

“The launch plans for both products will be communicated shortly after concurring with partner Mylan,” the company said.

Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses, it added.

Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with 20 employees.

It currently has seven manufacturing facilities with research laboratories, and has more than 4000 employees.