Generic DOACs take over half of Xarelto mkt

Patent expiration drives decline in original prescriptions… Eliquis -27%, Xarelto -6%

Q1 Xarelto generics occupy 49% share of mkt…Lixiana generics expand to 25%

Market leader Lixiana patent to expire in November…30+ generics expected

The KRW 260 billion direct oral anticoagulant (DOAC) market is seeing rapid generic penetration. Generic share has reached 49% for Xarelto (rivaroxaban) and 25% for Eliquis (apixaban).

Industry attention is now focused on Lixiana (edoxaban), whose generics are expected to launch later this year. As the top-prescribed product, its generic entry is expected to reshape the entire DOAC market. Fifteen companies have already received approvals and are waiting to launch.

DOAC market at KRW 60.8 billion in Q1…decline since Q3 2024

According to market research firm UBIST, outpatient prescriptions in the domestic DOAC market totaled KRW 60.8 billion in Q1.

Overall, the market has been declining since Q3 2024, due to patent expirations, generic launches, and the resulting price cuts.

Xarelto’s patent expired in Q2 2021. Since then, 65 companies have launched Xarelto generics. These generics have rapidly increased their prescription volume since then. Since Q3 last year, they have maintained a market share of around 49% in the rivaroxaban market. This means that, just over four years after the launch of generics, their market share has expanded to a level comparable to that of the original product.

Amid the rapid growth of generics, prescriptions for the original Xarelto have been steadily declining. Q1 prescriptions were KRW 7.2 billion, down 6% YoY, roughly half of the KRW 16.3 billion recorded in Q3 2021.

Competition among generic products is also intensifying. As of Q1, Hanmi Pharm’s ‘Riroxban’ took the top spot among generics with prescription sales of KRW 2.2 billion, a 3% increase YoY. In contrast, the products ranked 2nd through 4th—Samjin Pharmaceutical’s ‘Rivoxaban,’ Chong Kun Dang’s ‘Riroxia’ and Daewoong Bio’s ‘Varelto’—all saw prescription sales decline by more than 10%.

As competition intensifies, the number of companies withdrawing from the market is also increasing. Last year, 14 products from six companies left the market due to the expiration of their validity periods. This year, market exit appears to be accelerating, with the validity periods of 38 products from 14 companies set to expire.

Eliquis generics reach 25% share just a year and a half after re-entry

Eliquis generics re-entered the market in Q4 2024. The generics were originally launched in June 2019. At the time, generic manufacturers released the products based on favorable rulings in the first and second instances of patent litigation. However, the situation reversed in April 2021 when the Supreme Court overturned the lower court rulings and ruled in favor of the originator, BMS. Generic manufacturers immediately withdrew from the market. This created a three-and-a-half-year gap in the market until the Eliquis composition patent expired last September.

Since re-entering the market, Eliquis generics have been gradually increasing their market share. The combined prescription value for Eliquis generics in the first quarter was KRW 3.2 billion, representing a market share of approximately 25% in the apixaban-based DOAC market. This is higher than the market share just before withdrawal (24% in Q1 2021). As of Q1, Chong Kun Dang’s ‘Liquisia’ and Samjin Pharmaceutical’s ‘Elxaban’ recorded KRW 1.4 billion and KRW 1.2 billion, respectively, taking the top two spots among generics. Prescription sales for other products were less than KRW 300 million.

In contrast, sales of the original Eliquis fell by 27% from KRW 13.5 billion to KRW 9.8 billion in just one year. Compared to the KRW 20.5 billion recorded in Q3 2024, just before the re-entry of generics, prescription sales have dropped to less than half in just a year and a half.

Lixiana, the current market leader, faces patent expiration by the end of this year… DOAC market to be reshaped with the entry of generics

Industry attention is now focused on the generics of Lixiana, the market leader. Lixiana’s composition patent expires this November. Generic companies have successfully circumvented the remaining patents.

Currently, 15 pharmaceutical companies, including Nexpharm Korea, DongKwang Pharm, Dongkook Pharmaceutical, Samsung Pharm, Shinil Pharma, Shinpoong Pharm, Ahngook Pharmaceutical, HK Inno.N, Ildong Pharmaceutical, Genuone Science, Union Korea Pharm, Korea Prime Pharm, Handok, and Hanmi Pharmaceutical, are awaiting the patent expiration with 35 generic product approvals already secured. With a KRW 120 billion market at stake, expectations among generic drug manufacturers are reportedly high.

Last year also saw a series of challenges to patents by generic companies. In 2023 alone, about 10 companies, including HLB Pharmaceutical, Daehwa Pharmaceuticals, Austin Pharma, CMG Pharmaceutical, Chong Kun Dang, Huons, Korea United Pharm, NBK Bio Korea Pharm, Myungmoon Pharm, and Boryung, filed patent invalidation suits and won their cases.

Challenges to the Lixiana formulation patent were conducted on a large scale in 2018 and concluded with a victory for the generic drug companies. Analysts suggest that a significant number of companies that were unable to avoid the patent at that time subsequently filed patent challenges in order to launch Lixiana generics. The pharmaceutical industry forecasts that about 30 companies, including those that have already received approval, will join the competition.

The original Lixiana further expanded its prescription volume ahead of the launch of generics. Lixiana’s prescription sales in Q1 reached KRW 31.8 billion, a 5% increase YoY. This marks the highest quarterly sales figure on record.

Lixiana was the last of the DOAC class of drugs to be launched. In South Korea, Xarelto (rivaroxaban) was approved in 2009, followed by Pradaxa (dabigatran) and Eliquis (apixaban) in 2011, then Lixiana in 2015. In the early stages of its launch, Lixiana ranked third in the market, trailing behind Xarelto and Eliquis. However, after partnering with Daewoong Pharmaceutical as its domestic co-promotion partner, it rose to the top of the market in 2019 and has been steadily increasing its prescription volume ever since.