Trajenta generics enter reimbursement pricing…

for their launch in June

The Trajenta series generated a market size worth KRW 120 billion…The diabetes market is flooding with medicines following last year

DPP-4 diabetes drug Trajenta tab.

The generic version of Trajenta (linagliptin), a DPP-4 inhibitor class, has applied for reimbursement pricing ahead of its launch in June.

 

This year, generic market is drawing attention to Trajenta.

 

With the exclusive rights for Trajenta is set to expire, after Forxiga and Januvia last year, the diabetes market is expected to see new competition this year.

 

According to industry reports on the 4th, Trajenta generics applied for reimbursement pricing.

 

Subsequently, the Health Insurance Review and Assessment Service (HIRA) started the pricing process.

 

It is expected that Trajenta generics would be listed on June 9 when the substance patent of the original drug expires.

 

Generic companies have confirmed the release date for June after winning the dispute over Trajenta’s unregistered substance patents.

 

In January, the Intellectual Property Trial and Appeal Board (IPTAB) gave a verdict validating the claims on patent challenges by five generic companies, including Genuonesciences, for invalidating three counts of Boehringer Ingelheim’s use patents for Trajenta.

 

Consequently, when the product patent expires on June 8, the generic companies are expected to enter the market based on the verdict.

 

The DPP4 inhibitor formulation patent, which is set to expire in 2027, remains on the patent list of the Ministry of Food and Drug Safety (MFDS).

 

However, most of the pharmaceutical companies have avoided this patent type.

 

60 Trajenta monotherapy generics and 204 Trajenta-duo (linagliptin+metformin) combination therapy generics have received approval.

 

Most known domestic pharmaceutical companies are set to enter the market.

 

Notably, generic companies have developed SR tablets unavailable in Trajenta-duo and have completed approval.

 

According to UBIST last year, Trajenta accumulated an outpatient prescription amount of KRW 61.3 billion and Trajenta-duo accumulated an outpatient prescription amount of KRW 62.1 billion.

 

Together, those two generated a KRW 120 billion-worth market.

 

The market size is comparable to Januvia (KRW 34.9 billion), Janumet XR (KRW 41.1 billion), and the Janumet series.

 

Following the expiration of Januvia's patent last year, over 200 products entered the market, and similar interests are observed for Trajenta generics as well.

 

However, Januvia generics occupied the market in advance in September.

 

As many pharmaceutical companies intensify their sales efforts to dominate the market, it is anticipated that they may not be able to put their efforts into Trajenta generics belonging to the same class as Januvia.