Asthma drug 'Monterizine' sales rise despite generic entries

KRW 3.7B→KRW 4.3B in a year…Monterizine Chewable Tab is the only available treatment for young children

The drug price has been maintained despite generic listing in October 2023…original-generic "different formulation"

Hanmi's asthma treatment, 'Monterizine,' successfully expanded its prescription sales over 10% Year-over-Year (YoY), despite the release of generics.

 

Generic drugs had been listed for reimbursement in October 2023.

 

The analysis suggests that Monterizine's continued sales expansion is because generic prices have not been reduced and, it maintains a strong market presence with its broader scope of use.

 

Prescription sales 14%↑despite generic releases… Monterizine Chewable Tab is the only available treatment for young children According to the pharmaceutical market research firm UBIST on November 8, Hanmi's Monterizine recorded prescription sales of KRW 4.3 billion in Q3, which is an increase of 14% over a year compared to KRW 3.7 billion in Q3 2023.

 

Monterizine is a combination drug containing the asthma treatment, 'Montelukast,' and the third-generation antihistamine, 'Levocetrizine.' Hanmi received approval for 'Monterizine Cap' in May 2017.

 

The following April, Hanmi changed the formulation and received approval for 'Monterizine Chewable Tab' designed to be taken by chewing.

 

After the launch of Monterizine Chewable Tab, prescription sales quickly expanded for the Monterizine series.

 

The combined prescription sales of Monterizine Cap and Monterizine Chewable Tab have increased by 8%, from KRW 7.9 billion in 2019 to KRW 8.6 billion in 2020.

 

It recorded KRW 9.7 billion in 2021, surpassing KRW 10 billion when the sales amounted to KRW 12.4 billion in 2022.

 

Last year, it recorded KRW 15.6 billion, a 21% increase from the previous year.

 

This year, Monterizine is maintaining solid sales.

 

In Q4 2023, it surpassed KRW 4 billion for the first time, generating KRW 4.3 billion to KRW 4.4 billion in sales each quarter.

 

Quaterly prescription sales of the original drug Monterizine (blue) and generics (ligt blue) (unit: KRW 100 million, source: UBSIT).

Interestingly, generics of Monterizine were launched in October 2023.

 

Typically, sales of original drug slow down after the generic launches, but Monterizine is following a different trend.

 

The analysis suggests that Monterizine Chewable Tab is showing a strong market presence with its broader scope of use.

 

The scope of use for the original Monterizine Cap and generics to Monterizine are limited to 'adults and adolescents at the age of 15 or older.' Monterizine Chewable Tab is prescribed to 'young children at the age of 6-14.' The analysis is that Monterizine Chewable Tab is widely used in the prescription market, especially because young children require frequent prescriptions in the case of asthma drugs.

 

Drug price has been maintained despite generic releases…the generics formulation is different from the original Additionally, one of the reasons for continued sales of Monterizine is that it remains the same price following the generics' releases.

 

Product photo of Hanmi

In September 2021, generics companies challenged four patent cases of Monterizine.

 

In September of the following year, they successfully avoided patents one after another.

 

After losing the first trial, Hanmi appealed to the patent court, but the company soon withdrew.

 

Since October 2023, Monterizine generics have launched.

 

Six products that met the requirement for the highest price by conducting bioequivalence tests became listed at KRW 886 per tablet.

 

14 products that did not meet the bioequivalence test because they were produced by contract manufacturing organization (CMO) became listed at KRW 753 per tablet.

 

The drug price of Monterizine was not reduced following the generic release.

 

The original drug price is automatically reduced by 30% when generics are released.

 

Monterizine drug price should have been reduced from KRW 886 to KRW 620, but it was not.

 

This is because the generics have been developed in a formulation different from the original.

 

The Health Insurance Review and Assessment Service (HIRA) reduces the original drug price by 30% in the first year when a product with the same formulation is launched.

 

In the following year, the HIRA further reduces the drug price of the original by 53.55%.

 

In this case, the 'same formulation' means the active ingredient, administration route, dosage, administration method, formulation, and efficacy·effects are matched.

 

The original Monterizine is available in capsules and chewable tablets.

 

Generic products received approval as tablets.

 

The government analyzed that the generics are not in the same formulation as the original Monterizine.

 

Therefore, the drug price of the original was maintained at KRW 886.