Monterizine generics prepare for release in Oct

Those that recieved first generic exclusivity

HIRA’s drug pricing calculation evaluations in progress... directly target the KRW 11.5 billion market

Hanmi Pharm’s asthma and rhinitis combination drug

Companies are preparing to release their generic versions of Hanmi Pharm’s Monterizine (Montelukast+Levocetirizin) in October at the earliest.

 

The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date.

 

According to the industry sources on the 8th, the price calculation process for Monterizine generics has been completed and it is expected to be listed with reimbursement next month.

 

HIRA is known to have been conducting pricing calculations for Monterizine generics that applied for reimbursement after being approved in August.

 

The generics, which received generic exclusivity, are expected to be released in October.

 

Unlike general drugs that take 3 months to reimbursement listing, it only takes 2 months for drugs that are granted generic exclusivity to reimbursement listing.

 

10 Monterizine generics that were granted generic exclusivity by HIRA are owned by Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical.

 

The difference between the generics and the original Monterizine Capsule is that the to-be-released generics are tablet formulations.

 

The pharmaceutical companies succeeded in avoiding Monterizine’s formulation patents with that difference.

 

The MFDS therefore granted them exclusive rights so other companies may not sell the same drug until May 2024.

 

Monterizine is Hanmi’s incrementally modified drug that it received approval in May 2017.

 

It is the world’s first combination of montelukast, which blocks the action of leukotriene that causes tightening of airway muscles, breathing difficulties, and runny nose, and levocetirizin hydrochloride, an antihistamine used to treat allergic rhinitis.

 

Hanmi demonstrated its combination’s superior efficacy compared to a single agent in a Phase III trial targeting domestic patients.

 

Monterizine exceeded the blockbuster drug threshold of KRW 10 billion for the first time last year.

 

Based on UBIST, the amount of its outpatient prescriptions was KRW 11.5 billion last year, up 24% points from the KRW 9.3 billion it had posted in the previous year.

 

Supported by its marketability, the generic companies are expected to make efforts to market their drugs early into their release.

 

An official from a related company said, "Because it is effective in relieving allergic rhinitis symptoms in patients with asthma and perennial allergic rhinitis, we expect to achieve high performance if we focus on marketing our product to HCPs in Korea." The current insurance ceiling price of Monterizine Cap is KRW 886/capsule.

 

Hanmi also owns a chewable tablet formulation of the same drug at the same price.