The first reverse growth of NOAC worth 230 billion won

Last year's original 4 items were 227.6 billion won in ↓ outpatient 2% year-on-year

Xarelto drops 22% on the impact of drug price cuts

Eliquis·Pradaxa·Xarelto·Eliquis

The NOAC market, which is worth 230 billion won, fell for the first time last year.

 

This is because the generic market for some items was opened and drug prices were cut.

 

Generics, which competed with the original "Xarelto," secured a market worth 9 billion won last year.

 

According to Ubist, a pharmaceutical market research firm on the 8th, the size of the outpatient prescription market in the NOAC market last year was 227.6 billion won, down 1.8% from 231.8 billion won the previous year.

 

NOAC has attracted attention as a drug that has a lower risk of bleeding side effects than warfarin, a conventional anticoagulant, and has a great thromboembolic effect.

 

A total of four original products are on sale.

 

Since the early 2010s, they have replaced warfarin and gained influence in the prescription field.

 

The NOAC market, which had been increasing every year, saw its annual prescription reverse growth for the first time in 2022.

 

With the emergence of generics of some items, the original drug price cut was made, and it entered a downward phase.

 

The representative one is Bayer's "Xarelto." Last year, Xarelto's outpatient prescription amount was 46.8 billion won, down 22% from 59.6 billion won the previous year.

 

Since its launch, Xarelto prescription solutions, which have continued to grow, have turned downward since last year.

 

The biggest blow is the original drug price due to the generic salary registration.

 

As of August 22 last year, the Ministry of Health and Welfare cut the drug price of all doses of Xarelto (2.5·10·15·20mg) by 30%.

 

This is because the Seoul High Court sided with the Ministry of Health and Welfare in a lawsuit filed by Bayer against the Ministry of Health and Welfare to cancel the Xarelto drug price cut.

 

The Xarelto price was scheduled to be lowered in May 2021, when generic was first listed, but the execution was suspended until the original ruling because Bayer filed a lawsuit that the drug price cut was unfair, saying that Generic was released before the patent expired.

 

The ruling was made after about a year and two months, and the drug price cut was finally confirmed.

 

Xarelto's quarterly prescription, which was between 14 billion won and 15 billion won, fell sharply to 11 billion won in the third quarter.

 

In the fourth quarter, it was 7.4 billion won, which is half the level before the drug price cut.

 

Compared to 2020, Xarelto's prescription in the second half of last year lost 40%.

 

The decline is expected to be steeper as additional Xarelto drug price cuts are expected this year.

 

The government will add the original drug price to 53.55% for the first time when generic is listed, and 70% for one year after adjusting it to 53.55%.

 

As a result, Xarelto, which was cut by only 30% last year, is expected to be cut by 23.5% to 23.6% this year.

 

The influence of Xarelto generic is also growing.

 

Last year, Xarelto generic products received 9 billion won in outpatient prescriptions, more than five times higher than the 1.6 billion won in the previous year.

 

Chong Kun Dang (2.9 billion won), Hanmi Pharm (1.5 billion won), and Samjin Pharm (1 billion won) are driving the growth of the generic market.

 

◆Lixiana and Eliquis increase without generic penetration, 160 Billion-scale Lixiana, the No.

 

1 in this market, raised its prescription amount by 89 billion won last year.

 

This is an increase of 5% compared to the previous year.

 

Lixiana is the latest NOAC formulation to enter the market.

 

There is a five-year difference from other drugs.

 

Despite being generic, Lixiana succeeded in reversing in 2019 by accumulating data through direct comparative studies with other drugs.

 

Analysts say that aggressive sales strategies with domestic companies also affected rapid growth.

 

Lixiana, which was 4.8 billion won in 2016, expanded its size from 20.9 billion won in 2017 to 39.5 billion won in 2018, 61.9 billion won in 2019, 72.9 billion won in 2020, and 84.8 billion won in 2021.

 

As of last year, Lixiana accounted for 41% of the original NOAC market.

 

BMS's Eliquis ranked second in the NOAC market.

 

Equis' prescription amount last year was 70.6 billion won, an 8% increase from the previous year.

 

The recent increase in Eliquis' sales is largely due to the withdrawal of generics.

 

Eliquis' growth slowed in June 2019 as it faced competition with generics.

 

Generic companies, which won the case until the second trial, preemptively released generic, and annual prescriptions rose by nearly 10 billion won in 2020.

 

During this period, Eliquis was 50.6 billion won in 2019 and 55 billion won in 2020.

 

Eliquis growth, which increased by 10 billion won every year, slowed down.

 

However, in April 2021, the Supreme Court reversed the previous ruling in the patent lawsuit and sided with BMS, taking a new turn.

 

Immediately after the ruling, the generics withdrew from the market en masse.

 

This is because BMS announced a claim for damages due to patent infringement.

 

The Mayor of Eliquis generic, which was 1.2 billion won in 2019 and 9.4 billion won in 2020, shrank to 5.4 billion won in 2021, when the Supreme Court ruled.

 

Last year, the prescription amount was 0 won as the generic benefit was deleted and all distribution inventory was exhausted.

 

Along with this, Eliquis' prescription amount, which had slowed down, recovered to 65.2 billion won in 2021, expanding by 10 billion won again.

 

Last year, it surpassed 70 billion won.

 

Generics that lost the lawsuit can only sell their products after September next year.

 

◆Pradaxa's sales have been on the decline for 5 years Sales of another NOAC, Pradaxa of Beringer Ingelheim, have been on the decline for the fifth consecutive year.

 

Pradaxa's prescription amount last year was 12.2 billion won, down 20% from 15.2 billion won in 2020.

 

Unlike other formulations, Pradaxa, which expanded its size in 2017, failed to exceed 20 billion won and turned downward.

 

Pradaxa's sales, which were 21.6 billion won in 2017, showed a clear decline to 19.6 billion won in 2018, 18.7 billion won in 2019, and 16.5 billion won in 2019.

 

Pradaxa, which has been pushed back from the competition with NOAC Original, is also out of the interest of generics.

 

According to the Ministry of Food and Drug Safety, 10 domestic companies were licensed for Pradaxa Generics in 2018, but none of them have been released on the market.

 

It seems that it is meaningless to compete in the Pradaxa market, which is only 10 billion won.