SunGen Pharma will launch Bivalirudin for Injection in the near future through a joint venture with Athenex Pharmaceuticals. This tentatively approved U.S. ANDA is exclusively licensed from the current ANDA holder, Hainan Shuangcheng Pharmaceuticals.   

U.S. Market Sales of Bivalirudin for Injection were $81.8 million for the year ending December 2018, according to IQVIA data. Bivalirudin is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots.

Dr. Isaac Liu, co-chief executive officer and president of SunGen Pharma, stated, “We are proud to add Bivalirudin for Injection to our growing portfolio of specialty injectable products, as well as announce our third injectable product launch. We will continue to look for opportunities to launch products to fill marketplace needs. The launch of Bivalirudin demonstrates a strong development to our partnership with companies around the world. We look forward to collaborating further to bring specialty pharmaceutical drugs to the market.”