Sale of Atozet generics exceeds its orignial in 1 year

...113 generics enter market

Prescription of Atozet generics in Q1 reach ₩22.7 billion … original ₩21.4 billion

Chong Kun Dang’s Lipilouzet becomes the first generic to receive approval

Authorized generics of Lipilouzet fail to effectively preoccupy market…latecomer generics fare better

The combination drug market for dyslipidemia treatment using the atorvastatin+ ezetimibe combination has increased twofold with the sudden growth of its generics.

 

Moreover, the market share of the generics exceeded that of the original in Q1 of this year.

 

The rapid expansion of the market last year is interpreted to be due to more than 100 companies joining in the competition after receiving approvals for their generics last year.

 

◆Atozet market increase twofold in 1 year due to entry of generics According to the market research institution UBIST on the 28th, outpatient prescriptions of atorvastatin+ ezetimibe combination drugs recorded ₩44 billion in Q1.

 

This is a 109% increase from the ₩21.1 billion in Q1 last year.

 

In other words, the market size had increased over twofold in just one year.

 

The preference and prescriptions for the ‘statin+ezetimibe’ combination had been continuously increasing in the front line over the past few years.

 

Sales of the original atorvastatin+ ezetimibe combination drug, Atozet, had also steadily increased during the period.

 

Prescriptions of Atozet in Q1 recorded ₩21.4 billion, a 1% increase from the same period of the previous year (₩21.1 billion) The market has expanded rapidly since Q2 last year when generic products started entering the market in earnest.

 

In fact, prescriptions of Atozet generics recorded ₩7.1 billion in Q2 last year, which surged to ₩15 billion in Q3 and ₩19.8 billion in Q4.

 

In particular, sales of the generics recorded ₩22.7 billion in Q1 this year and exceeded that of the original (₩21.4 billion).

 

A lot of Atozet generics entered the market after Q2 last year.

 

Chong Kun Dang opened up the door for the entry of generics.

 

Chong Kun Dang received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet in October 2020.

 

In January of the following year, 21 companies received approval for their authorized generics of Lipilouzet.

 

Authorized generics refer to already approved generic products with different packaging.

 

Latecomer generics joined the competition in February.

 

89 companies received approval for Atozet generics then, and two more companies joined in June last year.

 

In total, 113 companies currently own Atozet generics.

 

Chong Kun Dang and other companies that were authorized to manufacture authorized generics of Lipilouzet released their products a month in advance.

 

The companies had entered the market by listing their products on the reimbursement list in April last year.

 

Other companies followed in May after receiving insurance reimbursement, totaling the number of competitors to 83.

 

◆Latecomers make rapid strides… authorized generics of Lipilouzet fail to preoccupy market Among the generics, Daewoong’s Litorvazet has made the most success.

 

Litorvazet sold ₩3 billion in prescriptions in Q1.

 

Following Litorvazet, Boryung’s L50 sold ₩2.1 billion, Jeil Pharm’s Lipitor Plus ₩2 billion, Yuhan Corp’s Atovamibe ₩1.9 billion, and HK.Inno.N’s Zepitor ₩1.4 billion.

 

What’s interesting is that only 2 of the Top 5 generics – L50 and Zepitor- are Lipilouzet authorized generics.

 

Even when broadening the scope to the top 10 generics, only 4 of the 10 items are Lipilouzet authorized generics.

 

Among Atozet generics, the first generic Lipilouzet’s price is highest at ₩1,037, and Lipilouzet authorized generics are priced at ₩881, with other latecomers including Litorvazet set at ₩637 or lower.

 

Lipilouzet received the highest price among generics at 53.55% of the original price by satisfying both the ‘direct bioequivalence testing’ and ‘Regulation on Registration of Drug Substances (DMF)’ requirements.

 

Unable to satisfy the direct bioequivalence testing requirements, authorized generics received a price 15% lower than that Lipilouzet.

 

Other latecomer generics had to receive a price even 15% lower.

 

The stepped pricing system that was implemented in July 2020 requires the price of latecomer generics to be set 15% lower when over 20 products of the same item are already listed.

 

In other words, the latecomer generics such as Litorvazet are showing good performance, increasing prescriptions by 61% compared to Lipilouzet Tab and by 71% compared to authorized generics of Lipilouzet Tab.

 

When considering that Lipilouzet and the authorized generics have been released a month prior to the latecomer generics, the drugs enjoyed little market preoccupation effect.

 

On the other hand, generic companies for authorized generics of Lipilouzet Tab had attempted to receive a pricing premium and preoccupy the market by paying an upfront payment to Chong Kun Dang but were unable to see as much profit as expected.

 

The industry analyzed that consignees including Chong Kun Dang, Jinyang Pharm, Dongkoo Biopharma, Withus Pharm, and Dasan Pharmaceutical had made the most profit.

 

Currently, Jinyang Pharm has the largest number of consignors.

 

The company has been manufacturing and supplying Atozet generics to 26 companies including Daewoong Pharmaceutical.

 

Chong Kun Dang is in charge of producing products for 21 companies including Boryung Pharmacuetical and HK Inno.N.

 

Also, Dongkoo Biopharma (20 companies), Withus Pharm (15 companies), and Dasan Pharmaceutical (11 companies) also CMO generics for other companies.