Atozet market, ↑ 225% in 2 years

Generic market share 62%

In the first half of the year, the Ezetimibe/Atorvastatin combination drug was 126.5 billion won, up 34% from the previous year

Since last year, generic prescriptions have overtaken originals

The hyperlipidemic complex drug Atozet prescription market has grown significantly.

 

It more than tripled in two years due to the entry of generic drugs.

 

About 100 generic products increased their market share to 60%, leading the market expansion.

 

Jeil and HK inno.

 

N stood out among generic products.

 

According to UBIST, a pharmaceutical research institute, on the 27th, the outpatient prescription amount of ezetimibe/atorvastatin combination drug in the first half of last year was KRW 126.5 billion, up 33.7% from the previous year.

 

Prescriptions for ezetimibe/atorvastatin combination drugs increased 35.4% YoY to 61.2 billion won in the first quarter and rose 32.1% to 65.3 billion won in the second quarter.

 

Compared to 30.2 billion won in the second quarter of 2021, the prescription amount of the ezetimibe/atorvastatin combination drug in the second quarter more than doubled in two years.

 

As Atozet's generics entered the market in droves, the market size expanded rapidly in a short period of time.

 

Until 2020, the Ezetimibe/Atorvastatin complex was one of Organon's Atozet products.

 

From 2021, more than 100 domestic companies entered the Ezetimibe/Atorvastatin market simultaneously, increasing the market size.

 

In October 2020, Chong Kun Dang received permission for Lipilouzet, a combination drug with the same ingredients as Atozet, after clinical trials.

 

At this time, 22 companies received permission for Lipilouzet's delegated generic products and were listed on the reimbursement list from April 2021.

 

From February 2021, 88 additional pharmaceutical companies received approval for Atozet generics, and they were listed as payroll in May, a month later than Lipilouzet delegated generics.

 

In June 2021, as two additional companies received approval for Atozet generic products, the number of domestic companies entering the Atozet market increased to 113 in total.

 

In the first quarter of 2021, Atozet's prescription amount recorded 20.1 billion won, but as generic products poured in, the ezetimibe/atorvastatin combination market expanded 50.2% to 30.2 billion won in the first quarter.

 

In the second quarter of last year, the prescription volume of the Ezetimibe/Atorvastatin combination soared by more than 224.9% in two years compared to before the introduction of generics.

 

Generic products led the growth of the Ezetimibe/Atorvastatin combination drug market.

 

In the second quarter of last year, Atozet's prescription amount was 25.1 billion won, up 25.0% from the first quarter of 2021, before entering the generic market.

 

This means that the original drug was not affected even by the containment of generic products.

 

In the second quarter of last year, prescriptions for Atozet's generic products were 40.2 billion won, up 46.0% from the same period last year.

 

The share of generics in the ezetimibe/atorvastatin combination drug market reached 61.6%.

 

Atozet's generic products overtook Atozet's prescription volume in the first quarter of last year, one year after its release, and the growth rate accelerated even more this year.

 

The entry of ezetimibe/atorvastatin combination drugs by domestic companies is the result of a competition to preoccupy high drug prices after the implementation of the revised drug price system.

 

According to the stepped drug pricing system, which was implemented as a result of the drug price reform in July 2020, when there are more than 20 identical products listed, the price of generics that enter as latecomers will be lowered by 15%.

 

If there are more than 20 identical drugs already listed, regardless of whether or not the highest price requirement is met, the drug price will be lower between “85% of the drug price that does not meet the two requirements” or “85% of the previous lowest price”.

 

In April 2021, Lipilouzet was listed at the same upper limit as Atozet, the first product with the same ingredient listed.

 

The upper limit of Lipilouzet 10/10mg was registered at 1037 won, the same as Atozet at the time.

 

Of the 21 delegated generics listed at the same time as Lipilouzet, 20 were priced at an upper limit of 85% of the highest price.

 

This is because it did not meet the requirement of the ‘direct bioequivalence test’, which is the highest price requirement for generic products.

 

Generic products must satisfy both the 'direct performance of bioequivalence test' and the 'use of DMF' in order to maintain a 53.55% upper limit compared to original drugs before patent expiration.

 

Each time one condition is not met, the cap is reduced by 15%.

 

Lipilouzet delegated generic 10/10mg 20 products were listed at 881 won, 15% lower than 1037 won.

 

However, all 78 Atozet generic 10/10mg items listed one month later were set at the upper limit of 637 won.

 

The highest price stayed at 61.4% of 1037 won.

 

As ‘85% of the price of drugs that do not meet the two requirements’ is applied according to the step-type drug pricing system, the upper price limit is about 30% lower than that of Lipilouzet’s commissioned generic, which entered the market a month earlier.

 

Among Atozet's generic products, Jeil Pharm's Lipitor Plus stood out with prescriptions of 6.3 billion won in 2Q.

 

Among generic products, Lipitor Plus' share reached 15.7%.

 

Lipitor Plus is jointly marketed by Viatris.