Indian biotechnology company Panacea Biotech has announced to have launched in the US Prasugrel (5mg & 10 mg), a drug indicated for reduction of thrombotic cardiovascular events in people with acute coronary syndrome, after receiving its first-to-file ANDA approval from the United States Food and Drug Administration (USFDA).
“Approval and launch of this first to file ANDA product is an important milestone to achieve growth in our US business,” said Dr Rajesh Jain, Joint Managing Director, Panacea Biotech Ltd.
Under the US law, Panacea Biotech is entitled for 180-days of shared marketing exclusivity for Prasugrel tablets. The company had earlier managed to get the tentative approval for this ANDA.
The product has been launched in the market by Apotex Corp., a Canadian-owned pharmaceutical company which is the exclusive sales and distribution partner of Panacea for Prasugrel in the US.
The annual sale of Prasugrel prior to the entry of generics in the market was around $600 million in the US.