Bivalirudin for Injection First Launched in U.S.

2020-03-08 16:50
News    Bivalirudin for Injection First Launched in U.S.
On 17 March 2020, Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) first launched Bivalirudin for Injection in the United States.
On the morning of March 17, the company held a U.S. launch ceremony for the product, and the first batch of products will arrive in the United States via Shanghai Shipping. This is the first batch of products exported to the U.S. after the resumption of Hainan's epidemic prevention and resumption of production. It is also the first time that the company has successfully exported the generic drugs to the original /research institute after successfully challenging the U.S. original drug market holders and patent holders.
Bivalirudin is a specific thrombin inhibitor with a reversible effect. As early as December 2016, the company submitted ANDA to the U.S. FDA. In May 2019, the company also submitted a PIV patent declaration to the FDA, and held the original research drug marketing authorization holder and patent Holder launches patent challenge notice. Because the original research company did not initiate any lawsuit against the company's patent for Bivalirudin for injection within 45 days after receiving the notification, the company successfully challenged the patent for Bivalirudin for Injection with ANDA.
On October 23, 2019, the companys ANDA for Bivalirudin for Injection was approved by the FDA, and the product also entered the US market 10 years ahead before the patent expired. The product is conducive to opening up the layout of overseas markets, laying an important foundation for the subsequent development of generic drug production in the U.S., and has a positive impact on the company's future operating performance.

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