Apotex partners with Panacea Biotec to launch first-to-file Effient generic

MUMBAI and Weston, Fla. — A new blood clot prevention generic has hit the market. Indian biotechnology company Panacea Biotec announced recently that its exclusive sales and distribution partner Apotex has launched its generic of Eli Lilly’s Effient (prasugrel) tablets.

The launch marks the start of a 180-day exclusivity period for the generic, which is available in both 5- and 10-mg dosage strengths. Before a generic hit the market, Effient’s annual U.S. sales were approximately $600 million, Panacea said. The company had previously received tentative approval for the drug in May.

“Approval and launch of this first-to-file … product is an important milestone to achieve growth in our U.S. business,” Panacea joint managing director Dr. Rajesh Jain said.

The drug is indicated to reduce thrombotic cardiovascular events, including stent thrombosis in patients with acute coronary syndrome whose conditions are managed with percutaneous coronary intervention.