Two years after Forxiga exit… Jardiance 34%↑, Dapa.N↑

Jardiance expands sole lead in SGLT2i monotherapy market with 34% growth

Forxiga generics climb from KRW 17.9B to 74.6B… DapaN’s sale gains momentum via indication sucession

Two years after the withdrawal of the SGLT-2 inhibitor ‘Forxiga (dapagliflozin)’ from the Korean market, ‘Jardiance (empagliflozin)’ is strengthening its dominant position in this market, expanding its prescription performance by over 30%.

Among the flood of generics launched following Forxiga’s patent expiration, HK inno.N’s Dapa.N has shown particularly strong growth. Industry observers attribute this largely to the product’s successful succession of indications from the originator.

Two years postexit… Jardiance prescriptions rise from KRW 58.1billion to 77.7billion

According to the pharmaceutical market research firm UBIST on the 21st, outpatient prescriptions for SGLT-2 inhibitor monotherapies reached KRW 164.9B last year. This represents a 17.9% increase compared with KRW 139.8 billion in 2023, just before Forxiga’s market withdrawal.

The market experienced substantial shifts surrounding Forxiga’s exit. AstraZeneca Korea decided to withdraw Forxiga from the Korean market at the end of 2023. The following year, it halted the domestic supply of new inventory, leaving only existing stock circulating in the market. In April 2024, the company voluntarily withdrew marketing authorization, followed by full reimbursement delisting in December, and completed its full withdrawal from the market.

Forxiga recorded KRW 55.5 billion in prescriptions just before its market exit in Korea. At the time, fierce marketing and sales competition unfolded in the SGLT-2 monotherapy market among competing brands and generic manufacturers to capture the over KRW 50 billion annual gap left by Forxiga. Analysts note that this competitive dynamic contributed to nearly 18% market expansion over the two-year period.

During this period, Jardiance’s prescription sales grew significantly. Jardiance's prescription sales, which were KRW 58.1 billion in 2023, increased to KRW 77.7 billion last year, marking a 33.8% growth. In this process, Jardiance strengthened its dominant market position. As of last year, Jardiance’s market share in the SGLT-2 monotherapy segment reached 47.2%, approaching half of total prescriptions.

A potential variable is the entry of Jardiance generics. Following the expiration of Jardiance’s substance patent last October, 23 generic versions entered the market. The market penetration of Jardiance generics this year could potentially influence the original drug’s dominant position going forward.

Another original product, Daewoong Pharmaceutical’s Envlo (enavogliflozin), also saw a significant increase in prescriptions around the time of Forxiga's withdrawal. Since its launch in May 2023, prescriptions increased from KRW 3.2 billion to KRW 10.6 billion in 2024, then to KRW 11.8 billion last year.

Forxiga generics mark KRW 74.6 billion combined... ‘Dapa.N’ sales surge with inherited indications

Forxiga generics have also successfully filled the void left by the original. Notably, HK Inn.N’s Dapa.N, which inherited Forxiga’s indications, has recently shown a particularly pronounced upward trend in prescription sales.

Forxiga generics were launched en masse in 2023 following the expiration of the original product's substance patent. A total of 86 companies obtained generic product approvals, with 65 of them launching products.

Within the overall SGLT-2 inhibitor market, prescription sales for dapagliflozin-containing products increased slightly from KRW 73.4 billion in 2023 to KRW 74.6 billion last year. The 2023 structure, which consisted of KRW 55.5 billion for the original Forxiga + 17.2 billion won for generics, was replaced by KRW 74.6 billion entirely from generics last year.

Among the generics, HK inno.N’s Dapa.N has demonstrated particularly strong prescription growth. In April 2024, AstraZeneca Korea withdrew Forxiga’s marketing authorization while simultaneously transferring clinical data to the company, enabling Dapa.N to inherit Forxiga’s indications.

Immediately after the indication succession, Dapa.N’s prescription growth was limited. However, the upward trend accelerated from the fourth quarter of 2024. Prescriptions, which stood at KRW 2.4 billion in 2024, surged more than fourfold to KRW 10.5 billion last year. Analysts suggest that the declining domestic supply of Forxiga shifted prescription demand toward Dapa.N.

Excluding Dapa.N, other Forxiga generics showed mixed performance. Last year, Daewoong Bio’s ‘Forxidapa’ recorded KRW 6.0 billion, Hanmi Pharmaceutical’s ‘Dapalon’ KRW 5.8 billion, and Boryung’s ‘Trudapa’ KRW 5.6 billion. Additionally, Aju Pharm’s ‘Daparil’, Dong-A ST’s ‘Dapapro’, Chong Kun Dang’s ‘Exiglu’, and Daewon Pharm’s ‘Dapawon’ exceeded KRW 3.0 billion in prescriptions.

In contrast, most companies recorded prescriptions below KRW 1.0 billion. Of the 65 companies that launched products, 49 reported annual prescription performance under KRW 1.0 billion. This suggests that only about one in four generic companies entering this market achieved the expected commercial outcomes.