Chong Kun Dang applied for combination of Januvia+Forxiga

24 companies, including consignment, have completed their permission

Developed Alvogen and SK Chemicals, available in September next year.

Chungjeong-ro Headquarters of Chong Kun Dang

A combination of diabetes treatments Januvia (Sitagliptin) and Forxiga (Dapagliflozin) is gaining popularity among domestic pharmaceutical companies.

 

Although it can only be released after September next year due to patent rights issues, many domestic pharmaceutical companies are developing products.

 

According to the pharmaceutical industry on the 6th, Chong Kun Dang recently applied for permission from the MFDS for a combination of Sitagliptin+Dapagliflozin.

 

Combination of Sitagliptin+Dapagliflozin succeeded in commercialization for the first time in Korea on the 21st of last month when Dapacombi of Daewon Pharmaceutical obtained permission.

 

Two days later, Dongkoo Bio's Sitaflozin, the same ingredient as Dapacombi, was approved.

 

On the 4th, 22 items from other pharmaceutical companies entrusted by Dongkoo Bio were approved and the number of related items increased to 24.

 

Pharmaceutical companies that started developing products for the purpose of product approval include Alvogen Korea, GL Pharm Tech, SK Chemical, and Theagen Etex.

 

Alvogen was approved by the MFDS in October 2020, GL Pharm Tech in March last year, SK Chemical in September last year, and Theagen Etex in December last year.

 

Chong Kun Dang seems to have applied for permission by completing the development ahead of them.

 

However, even if commercialization is successful, it is expected to be after September 2023, when Januvia's material patent ends.

 

The reason why many domestic companies are developing products is that commercial expectations are high.

 

This is because the two components are the flagship items of SGLT-2 and DPP-4 inhibitors, which are currently leading the diabetes treatment market, and the proportion of prescriptions using both drugs in combination at the treatment site is high.

 

Based on UBIST, Januvia's outpatient prescription amount in the first half of last year was 21.2 billion won, and Forxiga's outpatient prescription amount was 18.3 billion won, ranking at the top of the market.

 

Combination of Januvia+Forxiga is the first product introduced by a domestic pharmaceutical company without an overseas original product, so expectations are high for market creation by domestic pharmaceutical company sales.

 

However, more than 20 pharmaceutical companies have already been approved, so it is difficult for any one company to be exclusive, which is considered a limitation in generating profits.

 

There are no overseas products with the same ingredients, but there are three overseas original products of the same category (DPP-4+SGLT-2) combination, so if they are reimbursed, there will be little market preoccupation effect.

 

In the industry, it is highly observed that top companies with large-scale customers such as Chong Kun Dang will eventually take the lead over other companies in terms of market share.