Daiichi Sankyo’s anticoagulant treatment Lixiana (ingredient: edoxaban) has faced a challenge by Korean drug firms seeking to avoid Lixiana’s substance and composition patents and release generic drugs.

According to the Intellectual Property Trial and Appeal Board (IPTAB), Boryung Pharmaceutical, Hanmi Pharmaceutical, and Chong Kun Dang filed a request to confirm the scope of Lixiana’s substance patent. Boryung is also seeking the confirmation of the scope of Lixiana’s composition patent.

The period of Lixiana’s substance patent lasts until Nov. 10, 2016, and that of the composition patent, until Aug. 21, 2018.

Approved in 2015, Lixiana is a latecomer in the non-vitamin K antagonist oral anticoagulant (NOAC) market. Other NOACs include Xarelto, Pradaxa, and Eliquis. Despite the late arrival, Lixiana has shown rapid sales growth.

According to U-BIST data, prescriptions of Xarelto, which has the most indications among NOACs, ranked first with 21.7 billion won ($19.3 million) in prescriptions in the first half. Eliquis came next with 15.4 billion won prescriptions, followed by Lixiana with 14.8 billion won.

With sales of NOACs expanding, local pharmaceutical firms have shown great interest in developing generic NOACs.

Hanmi and SK Chemical have obtained an exclusive license to sell Bayer Korea’s Xarelto for nine months from Oct. 4, 2021, to July 3, 2022.

Targeting Pradaxa, Hanmi, Ahn-Gook Pharmaceutical, Dasan Pharmaceutical, and Huons are developing similar remedies with a different base.

In June, local drug companies had to suspend their move to release generic drugs against BMS’ Eliquis, as the patent court overturned the patent trial and appeal board’s decision and recognized the validity of the Eliquis patent.

lhs@docdocdoc.co.kr

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