Natco Pharma’s marketing partner Mylan has received the approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva’s Copaxone 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.
The launch plans for both products will be communicated shortly after concurring with its partner Mylan. 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 around $700 million and for the 40 mg/mL dose of around $3.64 billion for the 12 months ending July 31, 2017, according to Quintiles IMS.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
