Lixiana generics set to enter the mkt in Nov…26 companies win nods

Market entry is expected on November 11, the day after the substance patent expiry, after the reimbursement calculation procedure

With the new drug pricing policy implemented, multi-product management criteria per identical formulation  will be applied for the first time

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Generics referencing the anticoagulant 'Lixiana (edoxaban tosilate hydrate),' which surpasses KRW 120 billion in annual outpatient prescription sales, have completed final regulatory authorization and are set to enter the market this November.

With Huons securing confirmation of the final patent-circumvention ruling and obtaining last-minute marketing authorization, 76 products across 26 pharmaceutical companies are set for market launch. However, as the "multi-product listing management" system is applied for the first time under the revised drug pricing policy implemented in August, pricing calculations across active ingredients and formulations have emerged as the primary market success variable.

According to the pharmaceutical industry on the 31st, the Ministry of Food and Drug Safety (MFDS) completed marketing authorizations for 76 generic products containing edoxaban (excluding the original drug) as of 6 PM. Products approved by the end of this month are scheduled to be listed on the Ministry of Health and Welfare's Pharmaceutical Reimbursement List in late October and released to the market, with National Health Insurance reimbursement coverage starting November 11, the day after the original drugs' substance patent expires on November 10.

Daiichi Sankyo Korea's original drug, Lixiana, is a leading product in the direct oral anticoagulant (DOAC/NOAC) market. It is indicated for ▲reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation ▲the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) ▲reducing the risk of recurrent DVT and PE.

According to pharmaceutical market research firm UBIST, outpatient prescription sales reached KRW 121.8 billion in 2025, up 4% compared to the previous year, maintaining its blockbuster status and driving strong development momentum among domestic pharmaceutical companies.

Follow-on developers also won patent dispute proceedings. Major pharmaceutical companies, including Samjin Pharm, Chong Kun Dang, Boryung, and Hanmi Pharm, resolved entry barriers by securing upheld claims (rulings of non-infringement) in negative scope confirmation trials against pharmaceutical composition Patent No. 1424843. In particular, Huons finalized its circumvention trial ruling and sequentially secured marketing authorization on August 31, joining the lineup for the coordinated November launch.

The revised drug pricing system is the most critical turning point for the Lixiana generic market. After the revised pricing framework takes effect on August 1, edoxaban generic drugs will be the first cohort subject to the strengthened "multi-product listing management" criteria (regulating listings starting from the 14th identical formulation product).

Among the 76 generic products approved to date by active ingredient, the original drug-identical 'edoxaban tosilate hydrate' is the most common, with 64 products across 22 companies. In comparison, the salt-modified formulation "edoxaban besylate hydrate" comprises 12 products across 4 companies.

By dose strength across all ingredients, the total includes ▲23 products (23 companies) for 15 mg ▲26 products (26 companies) for 30 mg ▲27 products (27 companies) for 60 mg. When evaluating only identical-ingredient (tosilate hydrate) tablets subject to multi-product management, all strengths- 15 mg (19 products), 30 mg (22 products), and 60 mg (23 products)- substantially exceed the 14-product threshold, meaning multi-product management criteria will be applied across all dosages.

Under the revised regulations, Innovative Pharmaceutical Companies receive a premium price floor of approximately 60% of the originator price, as before, with an additional three years granted for domestic manufacturing to maintain the premium price for up to four years. In contrast, conventional generics meeting baseline criteria—such as in-house bioequivalence testing and Drug Master File (DMF) registration—are priced at 45% upon initial listing, while generics fulfilling only one criterion are priced at 36%.

When the multi-product listing management criteria per identical formulation are applied on top of this, prices will be adjusted downward after one year. Generics initially priced at 45% will drop to 38.25%, while products listed at 36% will decrease to 30.6%. Consequently, most tosilate hydrate tablets sharing the originator's active ingredient will struggle to avoid additional price-cut penalties across all dose strengths after one year.

Conversely, products exempt from these regulations have gained a price-defense advantage. Salt-modified therapeutics (12 products), such as the 'edoxaban besylate hydrate’ formulations approved for Hanmi Pharm, Yuhan, Light Pharm Tech, and Genuone Sciences, along with the orally disintegrating tablet (ODT) formulation developed in-house by Dong-A ST, are excluded from the new multi-product listing management criteria.

A pharmaceutical industry official projected that "Intense competition is anticipated, with 76 products entering the KRW 120 billion market simultaneously," adding, "Under the revised drug pricing policy, profitability gaps among pharmaceutical companies will widen depending on Innovative Pharmaceutical Company certification status and the possession of salt modifications or specialized dosage formulations."