Only 15 of the 61 Trajenta generics will be released in KOR

due to first generic exclusivity issue

Other products cannot be released until March next year... Companies seek to receive approval for combination drugs instead

Despite the expiry of the substance patent of the DPP-4 inhibitor diabetes drug Trajenta (linagliptin) set for the 8th of next month, most of its generic versions will not be launched at that time.

 

Only products with the first generic exclusivity will be released, and the rest will only be allowed sale in March next year after the sales ban period is lifted.

 

According to industry sources on June 28, a total of 15 generic versions of Trajenta will be listed with reimbursement on June 9.

 

On the day, the following pharmaceutical companies will be launching generic versions of Tragenta: Korea Arlico Pharm, Hutecs Korea Pharmaceutical, Alvogen Korea, Aju Pharmaceutical, Boryung Pharmaceutical, Hanlim Pharma, Dongwha Pharmaceutical, Ildong Pharmaceutical, Hana Pharm, Kukje Pharm, KyungDong Pharm, Shinil Pharm, Huons, Daewon Pharm, and DonKoo Bio&Pharma will release generic versions of Trajenta monotherapy.

 

The absence of large generic companies in the monotherapy market is notable.

 

This is in contrast to the 29 companies releasing the linagliptin 5mg + metformin hydrochloride 1g combination drug.

 

The reason why only 15 companies, mainly small and medium-sized pharmaceutical companies, are launching Trajenta generic monotherapy is due to the first generic exclusivity.

 

The 15 companies received the right to first generic exclusivity in February 2019.

 

They were able to avoid Trajenta’s crystalline patent and secure the right to market the drug first upon their approval.

 

The companies will have exclusive rights to market the drug until March 8, 2025.

 

This means that before March 8, 2025, the sale of drugs that are identical to the products that have obtained first generic exclusivity is prohibited.

 

42 generic drugs have been approved, excluding 19 that have obtained first generic exclusivity.

 

These can only be launched after March 8th of next year.

 

Their launch date has been delayed by 9 months due to the failure to obtain the first generic exclusivity rights.

 

As it is important for generic products to preoccupy the market, the products that failed to obtain first generic exclusivity are now put in a much more disadvantageous position as they would have to enter the market 9 months later than the competitors.

 

In response, 4 companies, including Mother's Pharmaceutical, received approval for salt-modified versions to bypass the first generic exclusivity.

 

Since salt-modified products are not identical to the original drug, they can be released regardless of the first generic exclusivity rights.

 

They will also receive a drug pricing premium, and be priced at KRW 675 per unit, making them the highest-priced among follow-on Trajenta monotherapies.