Apixa-ban, chemical name l-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl) phenyl]- 4, 5, 6, 7- tetrahydro- 1H-pyrazolo [3, 4-c] pyridine- 3-carboxamide, CAS number: 503612-47-3.

Apixa-ban is an oral selective inhibitor of activated factor Xa, jointly developed by Pfizer and Bristol-Myers Squibb, and obtained the European drug regulatory agency's production license on May 20, 2011 for the prevention of elective hip joint surgery or venous thromboembolism in adult patients undergoing knee arthroplasty.

Apixa-ban was the first to be approved for marketing in the European Union in May 2011, and was approved for marketing by the US FDA in December 2012. It is used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and prevent the formation of deep vein thrombosis. In 2012 It was approved for listing by PMDA in Japan in December 2013, and was approved for listing in China in January 2013, and was included in the National Medical Insurance Catalog in 2017.

Apixa-ban has become a mainstay of both BMS and Pfizer since it was first approved a decade ago, but the $10 billion blockbuster will also face generic competition.

In 2017, BMS and Pfizer initiated patent infringement lawsuits against 25 generic drug companies that had submitted marketing applications to the FDA. In August of the same year, the USPTO granted Eliquis a key composition patent, extending its protection from February 2023 to November 2026. Another formula patent for Apixa-ban is valid until 2031.

Compared with foreign markets, the competition for Apixa-ban in my country is more intense.

In 2013, Apixa-ban Tablets was launched in China for the first time, and has always been exclusively sold by BMS. Until 2019, Hansoh Pharmaceuticals obtained the first generic listing through patent litigation, and the domestic patent rights of BMS were also announced to expire.

Since then, domestic pharmaceutical companies have submitted generic drug applications for listing.

Up to now, in addition to the original manufacturer, there are more than 27 domestic enterprises with production approval for Apixa-ban, including Changzhou Hengbang Pharmaceutical, Chia Tai Tianqing, Kelun Pharmaceutical, Qilu Pharmaceutical, Qingfeng Pharmaceutical, Jiangsu Jiayi Pharmaceutical wait.

With the normalization of centralized procurement, it can be predicted that the competition in the domestic market of Apixa-ban will become more intense in the future.