'Lixiana' dominates the DOAC market in KOR

Major DOAC products face a shift in the market…Eliquis 'slowdown,' Xarelto 'drop'

Xarelto generic, catching up with the original products…generic version of Eliquis awaits release

Patent expiration variable forecasted

(clockwise from top-left) Lixiana, Eliquis, Pradaxa, and Xarelto.

Daiichi Sankyo Korea’s 'Lixiana (edoxaban)' continues to dominate the market for Direct Oral Anti-Coagulant (DOAC).

 

BMS’s 'Eliquis (apixaban)' sales have recently experienced a slowdown, and Bayer’s 'Xarelto (rivaroxaban)' prescription performance significantly dropped after the generic launch.

 

The sales of Xarelto generic nearly chased the original product three years after its launch.

 

The pharmaceutical industry eyes on the substance expiry of Eliquis this September.

 

Eliquis generics that withdrew from the market after the Supreme Court’s ruling last 2021 may re-enter the market around the time of patent expiry, and a significant shift in the market is expected.

 

Lixiana, 9% up in one year… Eliquis growth has been stalled According to medical market research firm UBIST, the market of DOAC treatment outpatient prescriptions in Q1 in South Korea amounted to KRW 62.9 billion, up 6% over a year compared to KRW 59.3 billion in Q1 last year.

 

The mechanism of action of DOAC treatment is based on directly affecting the blood coagulation factor, thereby preventing blood clots.

 

It is expanding its usage as it replaces warfarin, which prevents vitamin K metabolism.

 

In South Korea, Xarelto was approved in 2009, followed by Pradaxa and Eliquis in 2011.

 

Pradaxa and Eliquis were also approved in 2015.

 

When the product was launched, it was called New Oral Anti-Coagulant (NOAC).

 

Ten years after its launch, the term was changed to Direct Oral Anti-Coagulant (DOAC) to indicate that the product directly affects the coagulation factor.

 

Four original products have seen a shift in the market.

 

The top-selling product, Lixiana, is strengthening its position as the market leader.

 

Prescription sales of Lixiana in Q1 of last year were KRW 27.7 billion, up 5% over a year compared to KRW 25.5 billion in Q1 of last year.

 

Although it was launched late, its prescription performance grew fast, reaching the top after 2019.

 

Last year, Lixiana became the first DOAC product to reach annual prescription sales of KRW 100 billion.

 

Quarterly DOAC prescription performance (unit: KRW 100 million, source: UBIST).

The second-ranked Eliquis has seen a stall in the growth recently.

 

Eliquis prescription sales have seen a 2% growth, increasing from KRW 19 billion in Q1 of last year to KRW 19.3 billion in Q1 of this year.

 

After Q3 of 2022, Eliquis prescription sales remain around KRW 19 billion.

 

As Lixiana sales grew fast while Eliquis sales stalled, the sales gap between the two products is widening.

 

The difference in the prescription sales between these two products in Q1 of this year amounted to KRW 8.5 billion.

 

It continues to widen every year, with a difference of KRW 4.4 billion in Q1 of 2022 and KRW 6.5 billion in Q1 of 2023.

 

Low Xarelto generics sales… Riroxban>Riroxia>Rivoxaban Over the last two years, Xarelto has experienced a significant decrease in prescription sales among the major DOAC products.

 

Xarelto’s prescription sales in Q1 this year amounted to KRW 7.6 billion, down 5% compared to KRW 8 billion in Q1 last year.

 

Its prescription sales declined by almost half over the past two years compared to KRW 14.8 billion in Q1 of 2022.

 

Xarelto’s prescription sales decline is likely due to its patent expiration and generic release that followed.

 

Xarelto generic was launched first in Q2 of 2021.

 

Xarelto’s prescription sales decline is likely due to its patent expiration and generic release that followed.

 

Xarelto generic was launched first in Q2 of 2021.

 

In Q3 of 2022, the stoppage of reducing drug prices for Xarelto due to an administrative suit was lifted.

 

When the pricing of Xarelto decreased, prescription sales started to decline.

 

Eventually, the presence of Xarelto generics increased while the sales of the original prescription gradually decreased.

 

Xarelto generics have gradually increased their prescription sales, nearly catching up with those of the original products.

 

As of Q1, the net prescription sales of generic amounted to KRW 5.9 billion, up 61% over a year compared to KRW 3.7 billion in Q1 of last year.

 

According to Q1 prescription performance report, Hanmi Pharm’s 'Riroxban' generated KRW 1.6 billion, CKD Pharm’s 'Riroxia' generated KRW 1.2 billion, and Samjin Pharmaceutical’s 'Rivoxaban' generated KRW 1.2 billion.

 

Trends in prescription performance of rivaroxaban-containing original product and major generics (unit: KRW 100 million, source: UBIST).

Pradaxa, another original DOAC product, is also facing a significant sales slowdown.

 

In Q1, Pradaxa prescription sales amounted to KRW 2.4 billion, down 25% year over year.

 

Eliquis’s substance patent set to expire this September…generic re-entry predicted The future variable in this market is the expiration of Eliquis' patent.

 

Eliquis' substance patent expires on September 9th of this year.

 

Generic manufacturers are waiting for the expiry of the substance patent, with Eliquis' formulation patent set to expire in 2031 after being invalidated.

 

Generic companies won both the first and second trials related to substance patents in 2018 and 2019, respectively.

 

After June 2019, Eliquis generic products were subsequently launched and have since been steadily growing in prescription sales.

 

However, the circumstances changed when the Supreme Court ruled on the reversal of the original decision in April 2021.

 

Generic companies have retrieved their products that could potentially infringe on the patent.

 

On the contrary, Eliquis successfully regained its dominant position in the market for DOAC treatments containing the apixaban ingredient.

 

With the substance patent set to expire this September, a flood of Eliquis generics is possible.

 

Major generic manufacturers have experience releasing their products and are expected to expand their influence in the market quickly.

 

On the other hand, it is expected that Eliquis will experience a sharp decline in prescription performance following the release of generics.

 

From BMS's perspective, there is no justification for delaying the government's price reduction decision following the generic reimbursement listing.

 

Due to this, the pharmaceutical industry anticipates that Xarelto will further strengthen its dominant position in the DOAC market.