Rivaroxaban Tablets, a RMB 40 Billion Antithrombotic Drug: Will CSPC Zhentai Overtake to Secure First-to-File Generic Approval?

On July 23, the review and approval status of CHIATAI TIANQING’s rivaroxaban tablets was shown as “Under Approval.” Previously (on May 27), Suzhou No. 3 Pharmaceutical Factory’s rivaroxaban tablets were indicated as “Documents Issued,” but no final approval notification was received. Whether CHIATAI TIANQING can surpass competitors to secure the first generic approval remains to be seen.

Rivaroxaban is a selective factor Xa inhibitor, jointly developed by Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It was first approved for marketing by the European Medicines Agency (EMA) on September 30, 2008, and received FDA approval for launch in the United States on July 1, 2011.

Figure 1: Global Sales of Rivaroxaban Tablets, 2013–2018

(Source: Menet’s Sales Database of Multinational Listed Companies)

Since its market launch, rivaroxaban has demonstrated strong market performance, ranking second in global sales among cardiovascular drugs in 2018, surpassed only by apixaban tablets. In 2018, Bayer reported sales of €3,631 million for rivaroxaban tablets, while Johnson & Johnson reported sales of $2,477 million, amounting to a combined total of approximately RMB 44.85 billion (based on the exchange rate as of July 29).

In June 2009, rivaroxaban tablets manufactured by Bayer entered the Chinese market under the brand name Xarelto, indicated for the prevention of venous thromboembolism in adults following elective total hip or knee replacement surgery. In May 2015, two new indications for rivaroxaban tablets were approved by the National Medical Products Administration (NMPA): treatment and prevention of deep vein thrombosis and prevention of pulmonary embolism, as well as stroke prevention in patients with atrial fibrillation.

Figure 2: Domestic Sales of Rivaroxaban Tablets in China, 2015–2018 (Unit: 10,000 Yuan)

(Source: Menet Database)

In recent years, the sales of rivaroxaban tablets in the domestic market (China's public medical institutions terminal + China's urban retail pharmacy terminal) have grown rapidly. In 2018, the sales reached nearly 1.9 billion yuan, with the original manufacturer Bayer exclusively dominating the market.

Recently, the China National Intellectual Property Administration issued a notice declaring one of Bayer’s formulation patents for rivaroxaban tablets invalid. In addition, the compound patent for this product is set to expire in 2020. Currently, competition among domestic manufacturers producing generic versions of rivaroxaban tablets is intense.

Figure 3: Generic Status of Rivaroxaban Tablets

(Source: One-click search from the Menet database)

According to data from Menet, there are as many as 66 accepted application numbers for generic rivaroxaban in the domestic market. Among these, 42 applications were filed under Category 6 for generics, with 40 already approved for clinical trials; 24 applications were filed under the new Category 4, involving companies such as Huahai, CHIATAI TIANQING, CSPC Ouyi, and Yangtze River Pharmaceutical Group.

On July 23, the review and approval status of CHIATAI TIANQING’s rivaroxaban tablets was listed as “Under Approval.” Previously (on May 27), Suzhou No. 3 Pharmaceutical Factory’s rivaroxaban tablets were shown as “Dispatched,” but no final approval notification was received. Whether CHIATAI TIANQING can outpace others to secure approval for the first generic version remains to be seen.

Source: Menet Database

Note: Data statistics are current as of July 29. Please feel free to point out any omissions or errors!

Original Title: [R&D] $40 Billion Antithrombotic Drug: Will CHIATAI TIANQING Overtake to Secure the First Generic Approval?