Lixiana leads the DOAC market..generics make advances

Lixiana’s Q1 sales reach KRW 117.5 billion… 45% share

Prescription of Eliquis declines with the reentry of generics…Xarelto’s sales slow down due to strong generic sales

Sales of Xarelto generics surged 47% in 1 year… will Eliquis generics also gain momentum?

(Clockwise from top left) Lixiana, Eliquis, Pradaxa, and Xarelto

Daiichi Sankyo's Lixiana (edoxaban) is further solidifying its dominance in the direct-acting oral anticoagulant (DOAC) market.

 

Prescriptions grew 12% year-on-year, and its share of the total market expanded to 45%.

 

Sales of Eliquis (apixaban) and Xarelto (rivaroxaban), on the other hand, have faltered.

 

Eliquis saw its first year-over-year prescription decline due to generic re-entry.

 

Xarelto generics have expanded prescriptions by 47% in a year, fiercely chasing the original.

 

Lixiana’s sales near KRW 120 billion a year...doubled in 5 years, accelerating its dominance in the market According to the market research institution UBIST, the outpatient prescription market for DOAC was KRW 260.1 billion last year.

 

This is a 7% increase from the KRW 242.8 billion in 2023.

 

DOACs are anticoagulants that prevent blood clots by directly acting on blood clotting factors.

 

It has replaced warfarin, which inhibits the metabolism of vitamin K, and expanded its use in the prescription field.

 

Xarelto was approved in Korea in 2009, followed by Pradaxa-Eliquis in 2011 and Lixiana in 2015.

 

When the products were first introduced, they were commonly referred to as NOACs (New Oral Anti-Coagulants), but as more than a decade has passed after their first approval, they are now referred to as DOACs (Direct Oral Anti-Coagulants), which means they act directly on clotting factors.

 

Major DOAC prescriptions by year (Unit: KRW 100 million, Source: UBIST)

Lixiana's dominance has been growing in the market.

 

Last year, prescriptions for Rixiana totaled KRW 117.5 billion, up 12% from KRW 105.3 billion in 2023.

 

Although Lixiana was one of the last DOACs to be launched in the market, it quickly ramped up prescriptions and has risen to become the market leader since 2019.

 

With annual growth of around 10%, prescription sales have nearly doubled in 5 years from KRW 60.4 billion in 2019.

 

Its share of the total DOAC market has also expanded from 33% in 2019 to 45% last year Eliquis’s sales decline for the first time...generics re-entry impact The remaining original drugs, on the other hand, have seen a recent decline.

 

Eliquis, the No.

 

2 product in the market, posted prescription sales of KRW 74.3 billion last year.

 

This is down 4% from KRW 77.3 billion in 2023.

 

Last year was the first time Eliquis' prescription sales declined year-on-year.

 

This decline in prescription sales is attributed to the reentry of generics and drug price cuts that followed.

 

Last September, Eliquis' substance patent expired.

 

This was followed by the re-entry of Eliquis generics into the market after a three-and-a-half-year break.

 

Eliquis generics have been launched into the market one after another since June 2019.

 

At that time, generic companies launched the product based on the verdict of the first and second material patent trials.

 

Since then, Eliquis generics have steadily increased prescriptions in the market.

 

However, in April 2021, the tide turned when the Supreme Court overturned the first and second trial rulings and ruled in favor of BMS.

 

The generic companies immediately withdrew their products from the market, and Eliquis regained its monopoly position in the apixaban-based DOAC market.

 

Quarterly prescription performance of Eliquis originals and generics (Unit: KRW 100 million, Source: UBIST)

The generic drugs returned last year upon the expiry of Lixiana’s substance patent.

 

At the same time, the price of the original product was reduced.

 

When the generic was launched in 2019, the price cut was suspended due to BMS's administrative litigation, but last year, the 30% price cut was applied.

 

Inluence of Xarelto generics expand...market share of rivaroxaban reach 46% Xarelto generated KRW 31.5 billion in sales last year.

 

That's up 2% year-over-year, but the long-term decline is steady.

 

Xarelto's prescription sales steadily declined from KRW 60.9 billion in 2021 to KRW 49.4 billion in 2022, then to KRW 31 billion won in 2023.

 

The decline in Xarelto prescriptions was driven by patent expiry and subsequent generic launches.

 

Xarelto generics have been available since the second quarter of 2021.

 

Then Xarelto's price cut, which had been blocked by administrative litigations, was enforced in the third quarter of 2022.

 

Xarelto prescriptions plummeted at the time of the price cut.

 

Meanwhile, Xarelto generics are rapidly gaining influence in the market.

 

Sales of Xarelto generics surpassed KRW 10 billion in prescriptions in 2022, their second year on the market.

 

By 2023, the market had grown to KRW 18.3 billion, and last year, it rose 47% to KRW 26.9 billion.

 

Generics' share of the rivaroxaban-based DOAC market expanded from 37% in 2023 to 46% last year.

 

The pharmaceutical industry expects sales of Xarelto generics to surpass the original in combined prescriptions this year.

 

Quarterly prescription performance of Xarelto original and generics (Unit: KRW 100 million, Source: UBIST)

Prescription sales of major generic products increased simultaneously.

 

Hanmi Pharmaceutical's Riroxban more than doubled from KRW 3.9 billion in 2023 to KRW 8.1 billion last year.

 

Sales of Samjin Pharm’s Rivoxaban increased 64% from KRW 3.2 billion to KRW 5.2 billion.

 

Sales of Chong Kun Dang’s Riroxia grew 10% year-on-year to KRW 5 billion.

 

Sales of Pradaxa (dabigatran) have been in a prolonged slump.

 

Last year, prescription sales fell to less than KRW 10 billion.

 

Will Eliquis generics return to the market and replicate past gains The future of this market will be determined by how quickly generic Eliquis products, which returned to the market in September last year, will expand their influence.

 

Some industry observers believe that the major generics companies will quickly expand their presence in the market, as they already have experience launching the products.

 

Eliquis generics generated prescription sales of KRW 1.2 billion in 2019 and KRW 9.3 billion in 2020.

 

In the first quarter of 2021, just before the Supreme Court ruling, the company's quarterly prescriptions expanded to KRW 3.6 billion.

 

Since most companies have Xarelto generics in stock, the expectation is that the two products will bring a synergistic effect.

 

On the contrary, some believe that it is unlikely that these generics will be able to achieve similar levels of prescription growth as Xarelto generics.

 

As Xarelto generics are already well established in the DOAC market, it is unlikely that they will be able to generate the same level of prescriptions as expected.

 

In addition, some believe that even if generic prescriptions of Eliquis do increase, this will then lead to a decline in Xarelto generic sales.