FDA nod to Natco's marketing partner Mylan for generic

Natco Pharma today said its marketing partner Mylan has received approval from the US Food and Drug Administration (FDA) for the generic version of multi-billion dollar multiple sclerosis drug - Copaxone - of Teva Pharmaceuticals.
The news gave fillip to the shares of Natco which hit the upper circuit of 20 per cent (Rs 954.35) a piece on BSE today.
"The launch plans for both products will be communicated shortly after concurring with its partner Mylan," Natco said.
According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/ml, containing a paragraph IV certification.

"Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time," Mylan said in a separate statement.
In 2015, the US Court of Appeals for the Federal Circuit again found that one of the patents of Teva's Copaxone was invalid.

Copaxone is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.
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 USD 700 million and for the 40 mg/ml dose of approximately USD 3.64 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.

Approximately 400,000 individuals in the US have MS and relapsing MS accounts for 85 per pent of initial MS diagnoses, Mylan further said.