Daiichi’s hold on Lixiana under pressure as Korean generics target 2026 launch

Lixiana’s (edoxaban) patent clock is now ticking loud enough for every generics player in Korea to hear.

Last Friday, Korean Drug, a local pharmaceutical firm, secured the Ministry of Food and Drug Safety’s go-ahead for a bioequivalence study of its 60-milligram edoxaban tablet, the 10th such trial approved nationwide and the latest sign that rivals are rushing the gates before Daiichi Sankyo’s blockbuster blood-thinner loses market exclusivity on Nov.10, 2026.

Korean Drug’s trial will enroll healthy adults in a randomized, open-label, crossover design under fasting conditions.

The green light lands just 10 days after Arlico Pharm received clearance for its own edoxaban trial under the working name Alixaban, and five months after HLB Pharmaceutical got the nod.

With barely 17 months left on the core composition patent and Daiichi’s formulation patent already neutralized by Korean challengers back in 2020, generic manufacturers are lining up to strike as soon as exclusivity lifts.

Major players including Dong-A ST, Handok, and Huons have already completed scope-confirmation studies or secured trial approvals, with several others close behind.

Daiichi’s legal defenses have kept the substance patent intact, most recently in October when the company fended off NVP Healthcare’s appeal and cemented exclusive rights to edoxaban’s “diamine derivative” core compound. But that victory only bought time. 

The formulation patent, valid on paper until August 2028, has already been circumvented by more than a dozen Korean companies, removing a key barrier to entry.

In the marketplace, Lixiana has enjoyed a commanding lead since 2019, overtaking earlier novel oral anticoagulant entrants including Bayer’s Xarelto, Boehringer Ingelheim’s Pradaxa, and Bristol Myers Squibb’s Eliquis. 

Last year, it generated roughly 117.5 billion won ($86 million) in Korea, up from 105.3 billion won in 2023. 

By the end of May this year, it had already pulled in about 50.6 billion won, according to UBIST data. Xarelto managed 31.5 billion won ($23 million) for all of 2024, while Pradaxa and Eliquis trailed at 9.9 billion won and 74.3 billion won, respectively.

Daiichi’s co-promotion pact with Daewoong Pharmaceutical may have helped reinforce hospital sales, but Korea’s price-driven tender system rarely favors incumbents once exclusivity evaporates.

Ten generic versions spanning 29 individual products have already cleared regulators, and latecomers are still filing scope-confirmation petitions.

Unless Daiichi finds a new way to hold the line, the Japanese drugmaker is on track to face a wave of generics ready to erode the market share Lixiana built since its rapid rise.