Forxiga Prodrug will be reimbursed for five months

before the patent expires

Dong-A ST is aiming to preoccupy the market that plans to launch before February next year

Patent litigation variable, the trial court succeeded in avoiding patent extension

Forxiga

Prodrug of Forxiga, an SGLT-2 diabetes treatment drug that Dong-A ST succeeded in avoiding patents through the development of drugs, will be listed on the 1st of next month.

 

It is five months before the expiration of the patent.

 

Earlier this month, it was possible because it succeeded in avoiding the duration of the material patent, which ends in April next year.

 

The Ministry of Health and Welfare recently disclosed this fact through an administrative notice of the revision of some details on the criteria and methods for applying for medical care benefits.

 

Dong-A ST's "Dapapro 10mg" will be newly registered on the 1st of next month and added to the standard for diabetes treatment.

 

Dapapro was granted permission on 23 August.

 

At that time, it was unclear whether Dapapro would be released before the expiration of its patent.

 

This is because Dong-A lost the second trial of a patent suit against AstraZeneca, a patent holder of Forxiga, in February.

 

Dong-A challenged the patent that Dapapro, a prodrug with a different chemical structure from the original, was not within the scope of Forxiga's material patent rights, but it was blocked in the second trial.

 

The Korean Intellectual Property Tribunal, which is the first trial, decided that it was not within the scope of rights as requested by Dong-A.

 

The ruling could have put Dong-A ST's early launch efforts in vain.

 

This is because there is not much time left until the patent expires.

 

However, Dong-A succeeded in avoiding patents on the 2nd of this month through a new patent lawsuit.

 

This time, it was argued that Dong-A ST products were not included in the rights on the 917th day of the duration added to a material patent for Forxiga.

 

For now, Dong-A ST is reportedly coordinating internally with the goal of releasing it before February next year if it is paid on the 1st of next month.

 

Currently, the Ministry of Food and Drug Safety has approved 225 products containing Dapagliflozin.

 

However, among them, only seven items from AstraZeneca, the original company, are on the market.

 

It is virtually difficult to sell the remaining items until the patent expires in April next year.

 

Dong-A ST is launching early alone.

 

It is the first SGLT-2 generics in Korea.

 

However, there is a possibility that the direction of patent litigation will emerge as a variable.

 

It is not known whether AstraZeneca, who lost the patent tribunal, will appeal.

 

If AstraZeneca expresses her intention to appeal, it will have to fight again in the patent court.

 

If the ruling is overturned in the patent court, the sale of the product must be stopped.

 

If there is a record of selling before then, AstraZeneca can also file a compensation suit based on this.

 

It is highly expected that Dong-A ST will not miss this opportunity to dominate the market.

 

Although it actively responds to patent lawsuits, it is expected to focus its efforts on marketing to preoccupy the market regardless of the outcome.

 

It is reported that Dong-A ST believes that the patent issue has been resolved and judges the early release before the expiration of the patent.