45 generics of Dapagliflozin+Sitagliptin were approved

Industries are also paying keen attention to its availability in September next year

MSD

Dapagliflozin+Sitaglipin from 45 companies, which can only be sold in September next year, has been approved.

 

Analysts say that the number of licensed companies is increasing as Dongkoo and Daewon, which succeeded in developing products, start supplying generics.

 

On the 28th, the MFDS approved 13 additional items of Dapagliflozin+Sitagliptin.

 

As a result, the number of Dapagliflozin+Sitaglipin increased to 45.

 

Forxiga is an SGLT-2 inhibitory diabetes treatment and has recently grown rapidly in the diabetes treatment market.

 

Forxiga, the original drug, recorded 42.6 billion won in outpatient prescriptions (based on UBIST) last year.

 

Januvia has long been leading the market with DPP-4 inhibitory drugs.

 

MSD's Januvia recorded an outpatient prescription of 459 won last year.

 

Two single drugs are widely used as diabetes treatments, and they are often used in combination.

 

Therefore, it is analyzed that when a combination of the two ingredients is released, the convenience of taking them will increase, and the prescription performance will increase.

 

Due to this expectation, it is interpreted that there were many requests for the production of consigned items from Daewon and Dongkoo.

 

So far, a total of 15 items have been approved by Daewon, including the company, and a total of 30 items have been approved by Dongkoo.

 

Daewon's Dapacombi 10/100mg and Dongkoo's Sitaflozin 10/100mg were approved, respectively, in December last year.

 

Both drugs are the first combinations to contain Dapagliflozin 10mg and Sitagliptin 100mg.

 

These drugs are believed to have signed contracts and applied for permission before July last year when the consignment BA restriction system was implemented.

 

However, these products are not immediately available for sale.

 

Both ingredients cannot be sold to the market before September 2023 because the material patents have not expired.

 

At the same time, there is no standard for insurance benefits for the SGLT-2+DPP-4 complex.

 

However, insurance benefits applied by the existing licensed complex systems are expected to be completed soon, so it is expected that insurance benefits will be easily obtained before the launch in September 2023.