Generic market share 13% after 'Trajenta' patent expiration

Original drugs, Trajenta·Trajenta Duo, 26%↓

Penetration rate↓ compared to previous cases of patent expiry for DPP-4 inhibitors used to treat diabetes

Generic products have expanded their market share to 13% just nine months after the patent expiration of Trajenta (linagliptin), a DPP-4 inhibitor for diabetes treatment.

 

Compared to previous cases of diabetes treatments in the same drug class that patents expired before Trajenta, generic products are analyzed to have slower market penetration.

 

Analysis suggests that the entry of generic products was blocked until early this year because they failed to receive priority marketing authorization, leading to passive product launches due to the original manufacturer’s active resistance.

 

Original prescription sales KRW 29.3 billion→KRW 21.6 billion in one year… and generics totaled KRW 3.1 billion According to UBIST, a pharmaceutical market research firm, on the 9th, the outpatient prescription market size for linagliptin-based diabetes treatments in the first quarter was KRW 24.7 billion.

 

It decreased by 16% year-over-year (YoY).

 

Prescription sales of the original products, Trajenta and Trajenta Duo, dropped.

 

Trajenta monotherapy sales dropped from KRW 14.7 billion to KRW 9.7 billion, a 34% decline, while the metformin combination therapy decreased from KRW 14.6 billion to KRW 11.8 billion, a 19% decline.

 

The combined prescription amount shrank from KRW 29.3 billion to KRW 21.6 billion, a 26% decrease.

 

Such an outcome is attributed to the expiration of the compound patent, the entry of generics, and the resulting price reductions.

 

The substance patent for Trajenta expired in June of last year.

 

Since then, generic products have been listed for reimbursement, leading to price cuts for the original products.

 

Trajenta price fell by 30% and Trajenta Duo by 11%.

 

Quarterly prescription sales of Trajenta original drug (dark green) & generics (light green).

 

(unit: KRW 100 million, source: UBIST)

The generics that entered the market immediately after patent expiration have gradually increased their market influence.

 

The combined prescription value of Trajenta and Trajenta Duo generics rose from KRW 1.8 billion in Q3 of last year to KRW 2.7 billion in Q4, and KRW 3.1 billion in Q1 of this year.

 

By company, as of Q1 of this year, KyungDong Pharmaceutical had the highest combined generic prescriptions for the single and combination products at KRW 600 million, followed by Daewon Pharmaceutical at KRW 500 million, Kyungbo Pharmaceutical at KRW 400 million, Yuhan and Hanmi Pharmaceutical each at KRW 300 million, and Boryung at KRW 200 million.

 

Except for one company, all generic manufacturers recorded less than KRW 500 million prescriptions in Q1.

 

The average prescription value per generic-launching company was just over KRW 100 million.

 

Penetration rate↓ compared to previous cases of patent expiry… Did the original company's defensive strategy work? Analysis suggests that generic market penetration has been somewhat slow, even with other diabetes drugs of the same class whose patents expired earlier.

 

For example, generics for 'Galvus (vildagliptin),' which lost patent protection before Trajenta, achieved a 39% market share three quarters after expiration.

 

Generics for 'Tenelia (teneligliptin)' reached a 48% market share nine months after patent expiry.

 

Generics for 'Januvia (sitagliptin),' whose patent expired in September 2023, had a 15% share three quarters after launch, two percentage points higher than Trajenta generics at the same period (13%).

 

Trajenta's generics have shown the slowest market penetration among DPP-4 inhibitor diabetes drugs.

 

The pharmaceutical industry suggests several analysis.

 

First, the lock on priority marketing authorization for Trajenta generics was lifted earlier this year.

 

After Trajenta's compound patent expired in May last year, 26 companies obtained priority marketing authorization and launched products.

 

Their priority marketing periods ended in March of this year.

 

Companies without those priority marketing authorization approvals were barred from launching generics for about ten months.

 

Only after those periods expired in March were an additional 12 companies, including Hanmi Pharmaceutical·Genuone Sciences, able to enter the market.

 

In addition, the original company, Boehringer Ingelheim Korea, actively defended its position by enforcing so-called 'unlisted patents' on Trajenta to defend generic launches.

 

Generic manufacturers faced the choice of launching products without entirely circumventing or invalidating those unlisted patents, risking patent infringement findings and damages in future litigation.

 

For these reasons, some companies reportedly held back on generic launches.

 

Only 15 firms listed the Trajenta monotherapy generic for reimbursement, whereas 39 listed the combination therapies, because reformulating the combination can partially avoid unlisted patent risks.

 

Indeed, of the 40 firms that listed a Trajenta Duo generic, 27 secured approval by changing the formulation to an extended-release tablet.

 

Strong brand loyalty to the original product in clinical practice may have also contributed.

 

Trajenta held the number 2 spot in the market for DPP-4 inhibitors for a long time after Januvia before its patent expiry, and despite generic entry, it maintains high loyalty in prescribing.