Dong-A ST’s Forxiga prodrug Dapapro 5mg listed for reimb

The low-stregnth prodrug will also be listed for reimbursement

5mg product to be listed at KRW 456... original product removed from reimbursement list

Following the reimbursement listing of the 10mg formulation of Dapapro Tab, the first follow-on drug of the antidiabetic SGLT-2 inhibitor Forxiga that had been developed by Dong-A ST, the 5mg lower-strength formulation of the drug is also soon to be listed with reimbursement.

 

When listed, Dapapro Tab 5mg will be the only dapagliflozin drug to be reimbursed and will have the potential to exclusively take over the market.

 

Reimbursement of the original Forxiga 5mg has been removed from the list.

 

According to industry sources on the 23rd, Dong-A ST’s Dapapro Tab 5mg will be listed at an insurance ceiling price of KRW 456 per tablet.

 

Dong-A ST had already launched Dapapro Tab 10mg with reimbursement for KRW 684 per tablet starting this month.

 

This was the first Forxiga latecomer to be listed for reimbursement.

 

Other Forxiga latecomers can only be released after the original drug’s patent expires in April.

 

Therefore, the company is expected to make every effort to preoccupy the market before the entry of its competitors.

 

Dong-A ST was able to release its product before patent expiry because its product is a prodrug that has a different chemical structure from the original.

 

However, once absorbed, the structure changes and the drug shows the same effect as the original.

 

Dong-A ST was able to invalidate 917 days added to Forxiga’s substance patent through its prodrug strategy, with the court ruling in favor of Dong-A ST in the passive trial to confirm the scope of the patent that was filed against Forxiga’s substance patent.

 

However, the final winner of the patent suit is yet to be determined as there is a high possibility that AstraZeneca, the patent holder, will appeal.

 

However still, DongA-ST decided to release Dapapro Tab 10mg to preoccupy the market.

 

The Dapapro Tab 5mg that will soon be listed will also be released to the market.

 

Moreover, DongA-ST’s Dapapro Tab 5mg is the only 5mg formulation to be reimbursed.

 

The original Forxiga 5mg Tab had been removed from the reimbursement list in October 2018.

 

As the 5mg strength is the recommended initial dose for patients who have not been treated with drugs for diabetes before in combination with metformin, it is expected to be quite well used in the market.

 

However, AstraZeneca is focusing on the main dose, 10mg strength of dapagliflozin.

 

This is why its combination drugs containing 5 mg of dapagliflozin, Xigduo XR Tab 5/500mg, and Xigduo XR Tab 5/1000mg still remain reimbursed.

 

Therefore, Dong-A ST will be on its own in the dapagliflozin 5mg market until AstraZeneca’s patent expires in April next year.

 

However, dozens of dapagliflozin follow-on drugs are expected to pour in after patent expiry.

 

In addition, Daewoong Pharmaceutical is also aiming for an early release of its SGLT-2 class new drug 'Envlo Tab.’ Therefore, competition among domestic companies in the SGLT-2 inhibitor market will intensify after April.

 

Therefore, from Dong-A ST’s perspective, the next four months will serve as an important period for them to measure the drug’s performance.