By Fineline Cube 
China-based Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) announced that the market filing for its generic version of bivalirudin has been approved by the Therapeutic Goods Administration (TGA) in Australia. Bivalirudin is a direct thrombin inhibitor used as an anticoagulant in patients undergoing various coronary surgeries combined with aspirin.
Bivalirudin Market History
Bivalirudin first received market approval in December 2000 in the US, where Sandoz Inc holds the patent until January 27, 2029. The originator subsequently obtained approvals in the European Union and China in September 2004 and February 2019, respectively.
Shuangcheng’s Regulatory Milestones
Despite the existing patent, Shuangcheng Pharma won a patent challenge and was granted temporary FDA approval for its generic version in October 2019. The drug passed the generic quality consistency evaluation (GQCE) in China in December 2022 and earned marketing approval in Saudi Arabia in February of last year. The latest approval from Australia’s TGA further expands Shuangcheng’s global market reach for its generic bivalirudin.-Fineline Info & Tech