Natco Pharma breached the 20% UC at Rs.954.35 within minutes of opening for trade today and is currently the top gainer on the BSE.

The company announced today morning that the U.S. Food and Drug Administration (FDA) has approved its marketing partner Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection. This is an AP-rated, substitutable generic version of Teva's Copaxone® 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection. It is used for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.

The company has said that 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 approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017, according to Quintiles IMS. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.

This is expected to generate revenue to the tune of around $300 million in FY19 and $350 by FY20, assuming the launching is done within the next 2-3 quarters. Its Srikakulam plant is expected to recieve establishment inspection report any time soon.