Januvia generics occupy 17% of market in 1yr

1 year after generics’ entry in bulk into the market

Combined prescriptions for Januvia and Janumet generics in Q3 amount to KRW 5.1 billion

More than 50 companies entered the market, but quarterly earnings per company were only KRW 100 million

Contrast with Tenelia’s case, where its generics occupied 51% of the market in the first year of release

Generic versions of the DPP-4 inhibitor diabetes drug ‘Januvia (sitagliptin)’ have expanded their share to 17% within a year of its launch.

 

In the pharmaceutical industry, the assessment is that their penetration rate is somewhat slower compared to other DPP-4 inhibitor generics.

 

In fact, the generic versions of Galvus (vildagliptin) and Tenelia (teneligliptin), which went off-patent before Januvia, gained market share similar to their original versions within a year of generic launch.

 

Q3Prescriptions of Januvia and Janumet generics in Q3 reach KRW 5.1 billion…market share rate 17% According to the market research institution UBIST on the 28th, the outpatient prescription volume of sitagliptin monotherapy and sitagliptin-metformin combination therapy was KRW 30.2 billion in Q3 this year.

 

This is down 13% from the KRW 34.8 billion in Q3 last year.

 

In the sitagliptin monotherapy market, the generic products generated a combined prescription amount of KRW 1.6 billion.

 

The original product, Januvia, generated KRW 5.8 billion during the period.

 

The generic versions accounted for 22% of the single-drug market.

 

In the sitagliptin-metformin combination market, the generics generated a combined prescription volume of KRW 3.5 billion.

 

In the same period, the original Janumet-Janumet XR generated KRW 19.3 billion.

 

The share of the generics in the combination market is around 15%.

 

The generics of the entire Januvia series generated a combined prescription volume of KRW 5.1 billion.

 

The prescriptions of the Januvia series generics have increased from KRW 2 billion in Q4 last year, KRW 3.6 billion in Q1 this year, KRW 4.5 billion in Q2, and KRW 5.1 billion in Q3.

 

During this period, the share of generics expanded from 7% to 12% to 15% to 17%, etc.

 

Quarterly prescriptions of Januvia, Janumet and their respective generics (Unit: KRW 100 million, Data: IQVIA)

By company, Hanmi Pharmaceutical recorded the highest cumulative prescription sales of KRW 2.4 billion over the past year.

 

Its single-agent drug ‘Sita Tab’ accounted for KRW 600 million and the combination drug ‘Sita Met XR’ accounted for KRW 1.9 billion.

 

This was followed by Seoul Pharmaceuticals, Kyungbo Pharmaceutical, and Daewon Pharm with cumulative prescription sales of KRW 1.5 billion each.

 

The rest of the companies have earned less than KRW 800 million in cumulative prescriptions over the past year.

 

The 21 generic companies have accumulated less than KRW 100 million in cumulative prescriptions over the past year, which renders the average prescription revenue per company to less than KRW 100 million.

 

Compared to Tenelia and Galvus...the speed of market penetration↓ The industry consensus is that the Januvia generics have not met expectations in terms of market penetration.

 

Januvia's patent expired in September last year.

 

Many companies were interested in the patent expiry of the product, as it had been the leading product in the prescription market for DPP-4 inhibitors worth KRW 600 billion a year.

 

A total of 89 companies received approval for their generic versions, 52 of which launched products.

 

Despite the rush to enter the market, the initial performance of the products has been disappointing.

 

In fact, compared to other products in the same class, such as Tenelia and Galvus, Januvia generics have been slower in gaining market share.

 

In the case of Tenelia-Tenelia M, the generic surpassed the original’s market share with a 51% share in its first year.

 

Tenelia's patent expired in October 2022.

 

Thirty-eight pharmaceutical companies launched generics simultaneously.

 

Since then, Tenelia generics have quickly penetrated the market.

 

In the first year of its launch, the combined generic prescription volume was KRW 13.1 billion, higher than that of the original's KRW 12.4 billion.

 

In the case of Galvus-Galvus Met, the generic’s share reached 44% in the first year.

 

The patent for Galvus expired in March 2022.

 

Since then, generic products have steadily increased prescriptions.

 

In the first year, combined generic prescriptions amounted to KRW 5.7 billion, significantly narrowing the gap with the original (KRW 7.4 billion).

 

One of the reasons why Januvia generics struggled to penetrate the market earlier in its launch is that the market for DPP-4 inhibitor class diabetes drugs is already saturated.

 

In addition to the Januvia series, the market is also dominated by originator products such as Zemiglo, Trajenta, Tenelia, Suganon, Galvus, Onglyza, Nesina, and Guardlet.

 

Of these, Tenelia, Galvus, and Trjenta generics have emerged after their patents expired.

 

Moreover, in the DPP-4 inhibitor diabetes market, overall prescription sales have been declining since the introduction of SGLT-2 inhibitors such as Forxiga and Jardiance.

 

In this context, the entry of large numbers of Januvia and Janumet generics into the market, as well as the fierce competition, led to performance below expectations.

 

This, coupled with supply and demand uncertainties during the initial launch of the generics, would have had a significant impact.

 

Generic companies struggled to secure volumes for a while after Januvia's patent expired, as manufacturers of sitagliptin raw materials were unable to keep up with the sudden increase in demand from domestic pharmaceutical companies, leading to supply instability for Contract Development and Manufacturing Organizations.