Lixiana solely leads DOAC mkt… Xarelto, Eliquis↓

Lixiana’s prescription sales in 1H reached KRW 59.9 billion... Market share expands to 59%

With patent expirations and generic entry, Eliquis and Xarelto see a decline in prescription sale

Patent for Lixiana, the market leader, will expire next year… over 20 generics await to enter the market.

(From top left clockwise) Lixiana, Eliquis, Pradaxa, and Xarelto

Original direct-acting oral anticoagulant (DOAC) drugs have faced mixed fortunes in the Korean market.

 

Prescription sales of Lixiana (edoxaban) increased by 8% year-on-year, solidifying its lead in Korea’s market.

 

Its market share in the DOAC market expanded to 49%, and the analysis is that Lixiana will continue its lead in the market until the expiration of its substance patent next year.

 

Eliquis (apixaban) and Xarelto (rivaroxaban) showed sluggish performance.

 

Lixiana saw a 30% decline in prescriptions due to price reductions following the launch of generics in the fourth quarter of last year.

 

Xarelto, whose patent expired earlier, has also shown a clear downward trend in sales in recent years.

 

DOAC prescriptions in the first half of the year reach KRW 122.4 billion...Lixiana solidifies sole lead in the market According to the pharmaceutical market research institute UBIST on the 28th, the domestic DOAC market prescription volume in the first half of this year was KRW 122.4 billion.

 

This is a 4% decrease from the KRW 127.1 billion it had rendered in the first half of last year.

 

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

 

They have replaced warfarin, which inhibits vitamin K metabolism, and are increasingly being used in clinical practice.

 

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

 

When the product first appeared, it was commonly referred to as NOAC (New Oral Anticoagulant), but as it has been more than 10 years since its initial approval, it is now called DOAC (Direct Oral Anticoagulant), referring to its mechanism of action that directly acts on coagulation factors.

 

Quarterly major DOAC prescriptions (Lixiana, Eliquis, Eliquis generic, Xarelto, Xarelto generics, Pradaxa)

Lixiana has further strengthened its lead in the market.

 

Lixiana’s prescription sales in the first half of this year reached KRW 59.9 billion, an 8% increase from the KRW 55.7 billion in the same period last year.

 

Lixiana was the last DOAC to be released, but the drug quickly increased its prescription sales and has maintained its market leadership since 2019.

 

With an annual growth of around 10%, prescriptions rose from KRW 60.4 billion in 2019 to KRW 117.5 billion last year, nearly doubling in five years.

 

Its share in the total DOAC market expanded to 49% in the first half of this year.

 

This means that Lixiana accounts for nearly half of the KRW 260 billion in the DOAC market.

 

The industry expects the market dominance to continue until the end of next year.

 

The substance patent for Lixiana will expire in November next year.

 

About 20 domestic pharmaceutical companies are expected to release generic versions at that time.

 

Currently, 13 companies have been approved to sell generic versions of Lixiana, including Nexpharm Korea, Dong-A ST, Samsung Pharm, Shinil Pharmaceutical, Shinpoong Pharm, Anguk Pharmaceutical, Ildong Pharmaceutical, Genuone Science, Union Korea Pharm, Korea Prime Pharm, Hutecs Korea Pharmaceutical, and Handok Pharm.

 

In addition, Samjin Pharmaceutical, HLB Pharmaceutical, Theragen Etex, and DongKwang Pharm have filed for an invalidation trial (passive scope confirmation trial) regarding the Lixiana formulation patent.

 

If they win the first trial, they will be able to release generic versions in line with the expiration of the substance patent, like other companies.

 

Furthermore, Alico Pharmaceutical and Korean Drug have been approved to conduct bioequivalence tests for the release of their generic versions of Lixiana.

 

Eliquis·Xarelto sales in clear decline…due to the release of generic versions and drug price cuts On the other hand, Eliquis and Xarelto are in a clear downward trend.

 

The sales decline of both products is analyzed to be affected by patent expirations and the subsequent entry of generics.

 

Eliquis sales fell 30% from KRW 38.8 billion in the first half of last year to KRW 27.1 billion in the first half of this year.

 

This is due to the impact of price reductions caused by the entry of generics.

 

Eliquis’ price was reduced by 30% in September last year.

 

Quarterly prescriptions of Eliquis and Eliquis generics

Eliquis generics re-entered the DOAC market in the fourth quarter of last year.

 

Eliquis generics were originally released in June 2019.

 

At that time, generic companies released their products based on the first and second instance rulings in favor of them in patent litigation.

 

However, the situation reversed in April 2021 when the Supreme Court overturned the first and second court rulings.

 

The generic drugs were immediately withdrawn from the market.

 

Following the expiration of Eliquis' substance patent in September last year, the generics returned to the market after three and a half years.

 

Eliquis generics have been expanding prescriptions since their return to the market, reaching KRW 200 million in the fourth quarter of last year, KRW 600 million in the first quarter of this year, and then KRW 1.1 billion in the second quarter.

 

By product, the situation is similar to that before the generics withdrew from the market three and a half years ago.

 

At the time, the top two generic products in terms of prescription sales, Chong Kun Dang’s ‘Liquisia’ and Samjin Pharmaceutical's ‘Elxaban,’ have maintained their positions as the top two generics even after re-entering the market.

 

Xarelto recorded sales of KRW 15.3 billion in the first half of this year, maintaining its prescription sales as in the same period last year.

 

However, the downward trend has been evident since 2021.

 

Compared to KRW 28.9 billion in the first half of 2021, sales have decreased by half in four years.

 

This is due to the entry of generic drugs.

 

Xarelto generics first appeared in the second quarter of 2021.

 

About 40 products were released simultaneously in line with the expiration of Xarelto’s substance patent.

 

Subsequently, prescriptions steadily increased, reaching KRW 4 billion in the first half of 2022, KRW 8 billion in the first half of 2023, KRW 12.4 billion in the first half of 2024, and KRW 13.7 billion in the first half of this year.

 

Quarterly prescriptions of Xarelto and Xarelto generics

By product, Hanmi Pharmaceutical's Riroxban recorded KRW 4.3 billion, Samjin Pharm’s Rivoxaban KRW 2.5 billion, and Chong Kun Dang’s Riroxia KRW 2.2 billion.

 

The remaining products had prescription sales of less than KRW 1 billion in the first half.

 

As sales of the original product slowed down, generics expanded their influence, and the market share of generics in the rivaroxaban-containing DOAC market reached 47% as of the first half of this year.

 

Another original product, Pradaxa (dabigatran), is struggling to gain traction in the DOAC market.

 

Pradaxa's prescription sales in the first half of the year were KRW 4.7 billion, a slight decrease from the KRW 4.8 billion in the same period last year.