Lixiana generics to be reimbursed in 2H

A wave of reimbursement applications anticipated ahead of November patent expiry

Will serve as first major test of new multi-product listing policy… innovative and quasi-innovative pharmaceutical company premiums also coming into play

With the expiration of the compound patent for Lixiana (edoxaban) set for later this year, a large number of generic products are expected to enter Korea's reimbursement list in the second half of 2026. However, the government's new multi-product listing management policy, which takes effect next month, is expected to serve as a key variable.

In addition, recent changes to pricing premiums for Innovative Pharmaceutical Companies, Quasi-Innovative Pharmaceutical Companies, and Supply Stability Leading Companies are expected to result in different reimbursement prices depending on each company’s designation status.

According to industry sources on the 8th, the new multi-product listing management system, which is scheduled to take effect next month, will apply to Lixiana generics set to  be listed for reimbursement in November.

According to pharmaceutical market research institute UBIST, Daiichi Sankyo's anticoagulant Lixiana generated KRW 121.8 billion in sales last year, up approximately 4% from KRW 117.5 billion the previous year.

A large number of follow-on manufacturers have already obtained marketing authorization in preparation for reimbursement listing immediately upon patent expiry.

As of this month, 28 generic products from 14 companies containing the same active ingredient as the original Lixiana, ‘edoxaban tosilate,’ have received regulatory approval. Because these products are expected to enter the reimbursement market simultaneously, they will become subject to the multi-product listing management system one year later.

The multi-product listing management policy is a new drug pricing mechanism introduced under the government's drug pricing reform. Under the system, once the number of products with the same formulation reaches 14 or more, reimbursement prices for products entering the market will be reduced after one year, with the pricing rate set to fall from 45% to 38.25%.

However, reimbursement prices will also vary depending on whether a company is certified as an Innovative or Quasi-Innovative Pharmaceutical Company. Innovative companies receive a 60% pricing premium, while Quasi-Innovative companies receive a 50% premium. Companies designated as Supply Stability Leading Companies are also eligible for a 50% premium. The premium remains in effect for a total of four years (1+3 years)

Accordingly, if an Innovative (or Quasi-Innovative) Pharmaceutical Company or a Supply Stability Leading Company is subject to the multi-product listing management policy, its 50–60% premium will be maintained for four years, after which the pricing rate will be adjusted to 38.25%.

As a result, companies such as Boryung, HK inno.N, and Dongkook Pharmaceutical will be able to retain the 60% premium for a certain period, while companies that do not qualify as Innovative Pharmaceutical Companies or Supply Stability Leading Companies will see their pricing rate reduced to 38.25% after one year, widening the reimbursement price gap.

An official at a domestic pharmaceutical company A said, "Apart from Lixiana, there are unlikely to be many cases subject to the multi-product listing management policy. It remains to be seen how companies will respond if the reimbursement price gap between products receiving premiums and those that do not becomes substantial."

Another key uncertainty is the implementation schedule for the Quasi-Innovative Pharmaceutical Company certification program, which has yet to be finalized. The government has only indicated that the program will be introduced after revisions to the Innovative Pharmaceutical Company framework are completed, leading industry observers to only expect the certification criteria and procedures to be finalized soon.

However, it will be physically impossible to complete the Quasi-Innovative certification process before the Health Insurance Policy Deliberation Committee decides on reimbursement listings for Lixiana generics at the end of October.

Another industry official from domestic pharmaceutical company B commented, "The criteria for Quasi-Innovative Pharmaceutical Companies are somewhat simpler than those for Innovative Pharmaceutical Companies because they mainly focus on sales, R&D requirements, and rebate-related issues. Fewer than 20 companies are expected to qualify. If the government issues the necessary notification and moves quickly, certification could be completed by the end of the year."