A change in the DPP4 diabetes market worth KRW 600 billion

Tenelia generics generated prescription sales of KRW 15.2 billion in Q1, 'up' 83% YoY

Galvus generics is soon to exceed the sales of the original…Januvia generics generating KRW 5.7 billion

Zemiglo maintains the leading position in the market for three consecutive quarters…Januva, previously No.1, saw a 33% 'drop' in sales over the year

(Clockwise from the top-left) Photos of Zemiglo, Trajenta, and Janumet·Januvia series.

The market for DPRR-4 inhibitor class diabetes treatment, valued at KRW 600 billion annually, is undergoing a significant shift.

 

Following the expiration of substance patents for major original products, generics have been launched, rapidly expanding their prescriptions.

 

At the same time, the growth of original products is experiencing a slowdown.

 

The prescription sales of Tenelia (teneligliptin) generics have increased by 83% year-over-year (YoY), resulting in a widening gap between the generics and the originals.

 

The sales of Galvus (vildagliptin) generics will soon surpass those of the original product.

 

Moreover, Januvia (sitagliptin) generics have rapidly expanded their market impact since September last year, achieving significant growth in less than six months.

 

Tenelia generics have grown significantly…prescription sales of KRW 8.3 billion→KRW 15.2 billion 'up' According to the medical market research firm UBIST on the 24th, the market size for prescriptions of DPP-4 inhibitor class diabetes treatment in Q1 was KRW 150.9 billion.

 

This represents a 4% decrease compared to KRW 156.5 billion in Q1 last year.

 

Recently, this market has transformed as the patents of major original products have expired one after another.

 

The patent of Novartis’ Galvus expired first in March 2022, followed by Handok’s Tenelia patent in October of the same year.

 

In September of last year, the patent of Januvia, which has been a top-selling drug, also expired.

 

After patents expired, the original products’ generics were released into the market one after another, rapidly expanding their prescriptions.

 

On the other hand, most original products have faced decreased prescription sales.

 

Among these, Tenelia generic has shown a significant growth in prescription sales.

 

Since Tenelia’s patent expiration, 37 pharmaceutical companies have launched generic versions of monotherapy Tenelia and combination therapy Tenelia M.

 

The Q1 prescription sales of these generics were KRW 15.2 billion, which is an 83% YoY increase.

 

Prescription performance of teneligliptin-containing originals vs.

 

generics (unit: KRW 100 million, source: UBIST).

In Q2 last year, Tenelia generics exceeded KRW 10 billion in net prescription sales, and by Q3, they had surpassed the original product sales.

 

The gap between the sales of generics and original products continues to widen.

 

In Q1 this year, generics expanded their market share to 55% in the diabetes treatment market containing teneligliptin.

 

On the other hand, the original products, Tenelia and Tenelia M, show a slowdown in performance.

 

In Q1 of this year, the combined prescription sales of these two original products amounted to KRW 12.6 billion, a slight increase from KRW 12.4 billion in the same period last year.

 

The prescription performance of Tenelia and Tenelia M expanded until Q3 of 2022, just before the patent expiration, reaching KRW 12.8 billion, and plateaued after that.

 

Generics of Galvus·Januvia are gaining more market share…while the sales of original products slow down Galvus generics are also gradually gaining influence and will soon surpass the original product.

 

In Q1, the combined prescription sales of Galvus·Galvusmet were KRW 6.1 billion, an 8% increase compared to KRW 5.7 billion YoY.

 

During the same period, prescription sales of the original products decreased by 7% from KRW 7.4 billion to KRW 6.9 billion.

 

The quarterly prescription sales of Galvus increased to KRW 12 billion just before patent expiration, but it has steadily declined since the release of generics.

 

As the generic prescriptions increased and that of the original drugs decreased, the gap between them significantly narrowed.

 

The difference between the originals and generics, which stood at KRW 1.7 billion in Q1 last year, narrowed by KRW 700 million over the year.

 

In the market for diabetes treatments containing vildagliptin, the generic market share expanded from 44% to 47%.

 

Galvus generics are expected to outperform the originals by the end of the year.

 

Changes in prescription performance of major DPP4i originals vs.

 

generics.

In Q1, the combined prescription performance of Januvia and Janumet generics reached KRW 3.6 billion.

 

Januvia's patent expired in September last year.

 

Over 100 companies obtained approval for related generics before the patent expiration.

 

Since Januvia maintained the leading position in the DPP-4 diabetes market, with prescription sales exceeding KRW 160 billion annually until just before the patent expiration, the product attracted much attention from generic manufacturers.

 

After the patent expiration, more than 50 companies have launched competing products.

 

The prescription sales of original products Januvia·Jaumet·Janumet XR decreased by 33% over the past year, dropping from KRW 37.9 billion to KRW 25.4 billion due to the release of generics and consequent price reductions.

 

In May, before Januvia's patent expired last year, Chong Kun Dang Pharmaceutical acquired all domestic rights to the Januvia series from MSD.

 

The total contract amount was KRW 45.5 billion.

 

Chong Kun Dang Pharmaceutical paid KRW 23 billion upfront to MSD headquarters and an additional USD 17 million (approximately KRW 22.5 billion) based on sales milestones.

 

Zemiglo maintains the leading position in the DPP-4 market…Januvia·Trajenta sales have been steadily decreasing Due to a rapid decline in the Januvia series' prescription sales has intensified competition for market leads.

 

LG Chem’s Zemiglo (gemigliptin)·Zemimet maintained their leading position by recording prescription sales of KRW 35 billion in Q1 last year.

 

Although the Zemiglo series was introduced to the market later than multinational pharmaceutical products, it has experienced rapid growth and surpassed KRW 30 billion in quarterly prescription sales in Q3 of 2020.

 

In Q3 of 2021, Zemiglo surpassed the Trajenta series, which recorded prescription sales of KRW 34.1 billion, by generating prescription sales of KRW 34.5.

 

Then, in Q3 last year, it even surpassed the Januvia series to take the lead in the market.

 

Quarterly prescription performance of major DPP4i diabetes treatment (unit: KRW 100 million, source: UBIST).

The Trajenta (linagliptin)·Trajenta-duo series secured the second position.

 

The prescription sales of these two products in Q1 of this year amounted to KRW 29.3 billion.

 

Compared to Q1 of last year, which recorded KRW 31.7 billion, there has been an 8% decrease over the year.

 

Their prescription sales are ranked second in the market but have a noticeable long-term downward trend.

 

The quarterly prescription sales of the Trajenta series have been steadily decreasing since reaching a peak of KRW 34.6 billion in Q4 of 2021.

 

Trajenta’s patent expires in June this year.

 

More than 60 pharmaceutical companies have obtained generic drug approvals and are waiting to enter the market.

 

With the release of generics, Trajenta's drug price will eventually decrease when the generic version containing the same active ingredient is listed for reimbursement.

 

According to analysts, prescription sales may continue to decline.

 

However, Trajenta has more than five unregistered patents.

 

It is uncertain whether domestic pharmaceutical companies will release generics immediately after the compound patent expires in June.

 

Releasing generics without overcoming unregistered patents could raise concerns about patent infringement for domestic pharmaceutical companies.