Priority mkt authorization for Trajenta generics ends

Due to the sales ban, the other companies waited for 10 months

The market share of generics is approximately 4%..."While it's late, there is still an opportunity available'

Product photo of Trajenta

As the priority marketing authorization for the generic version of Trajenta (linagliptin), a DPP-4 inhibitor used to treat diabetes, launched last year will end on March 8, generics that have been waiting for 10 months will be launched.

 

The list of generics to be launched includes Hanmi Pharmaceutical and Genuone Sciences.

 

According to the industry sources on February 23, 12 generics containing linagliptin such as Hanmi Pharmaceutical's 'Linaglo Tab' will be added to the reimbursement list, starting March 9.

 

The market for a generic version of Trajenta became available after the patent of the original drug expired in June 2024.

 

At that time, 16 monotherapy products were launched into the market.

 

Only a portion of the 60 approved items have been launched because of the priority marketing authorization.

 

Sixteen pharmaceutical companies have avoided two Trajenta patents, and they challenged the market when the composition patent expired on June 8, 2024, following the substance patent expiration.

 

These companies also obtained priority marketing authorization, a policy established in February 2019 granting items meeting the first approval·patent avoidance criteria.

 

The priority sales were approved for 10 months, between June 9, 2024, and March 8, 2025.

 

During this period, generics with the same ingredient cannot be launched.

 

Pharmaceutical companies with priority marketing authorization include Dongkoo Bio, Daewon Pharmaceutical, Jeil, Huons, Shinil Pharma, KyungDong Pharm, Kukje Pharm, Hana Pharm, Ildong Pharmaceutical, Dong Wha Pharm, Hanlim Pharmaceutical, Boryung, Aju Pharm, Albogen Korea, Hutecs Korea Pharmaceutical, and Arlico.

 

These companies took the market for the first 10 months and gained a favorable spot.

 

As priority marketing authorization ends on March 8, these companies will face new competitors.

 

Changes to the competition landscape are expected since the late-launching group includes big pharmaceutical companies with established sales, such as Hanmi Pharmaceutical.

 

Among the later-launch products, Hanmi Pharmaceutical's 'Linaglo Tab' is priced the same as the highest price (KRW 510) of the previous generics for meeting all criteria requirements and receiving credit (68%) for innovative-type pharmaceutical companies.

 

Genuone Sciences' 'Tra-K Tab' and Aprogen Biologics 'Linahana Tab' will be reimbursed at KRW 447 for meeting all criteria requirements and receiving credits for first generics (the number of drugs with the same ingredient below 19, 59.5%).

 

Products from Jinyang Pharm, Nexpharm Korea, DaehanNupharm, PharmGen Science, Genupharma, Withus Pharmaceutical, and Unimed Pharm meeting only one of the criteria requirements will be listed for reimbursement at KRW 341.

 

Il Wha's 'Trina Tab 5mg' will be listed at KRW 402, which has been priced lower than the estimated price.

 

However, credited prices for newly reimbursed drugs will end in June, at the same time as the products launched last year, because they were added to the reimbursement list late.

 

After three months, the ceiling prices for all items will be adjusted to 53.55% of the highest price.

 

Meanwhile, according to the market research firm UBIST, generics with linagliptin recorded KRW 4.7 billion in prescription sales between the launching date of June 2024 and December.

 

The market share is about 4%.

 

As they are in the early phases of the market launch, robust growth has not been achieved.

 

It will likely present an opportunity for generic companies to launch late.

 

An employee of the pharmaceutical industry said, "The group with priority marketing authorization launched 10 months earlier, but it has been reported that they did not achieve noticeable growth due to the original drug." Adding, "This will present an opportunity for the second group to launch." The sales for the original drugs Trajenta·Trajenta Duo decreased by 16%, from KRW 123.5 billion to KRW 103.9 billion.

 

Despite a 30% reduction in mandatory drug pricing, they defended well.