Panacea Biotec has expanded its existing collaboration with Apotex, the largest Canadian-owned pharmaceutical company, for sales & distribution of Prasugrel 5mg and 10mg tablets (generic version of Eli Lilly's Effient) in the USA. The company has signed an exclusive License and Supply Agreement with Apotex for this purpose. Under the terms of the agreement, Apotex shall be responsible for sales & distribution of the product in the USA and Panacea Biotec shall be responsible for manufacturing and supply.
Panacea Biotec has already received tentative approval from USFDA for its Paragraph — IV first to file ANDA of Prasugrel Hydrochloride 5mg and 10 mg tablets. Under the provisions of the Hatch-Waxman Act, Panacea Biotec will be entitled to 180 days of shared marketing exclusivity for Prasugrel Hydrochloride upon USFDA approval.
Prasugrel is currently having annual sales of approximately $600 million in USA and is indicated for reduction of thrombotic cardiovascular events (including stent thrombosis) in people with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI).
Panacea Biotec is a leading biotechnology company with established research, manufacturing and marketing capabilities. It is one of the largest vaccine producers and leading Biotechnology Companies in India.
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