Capture the Diabetes Medication Market... The 'Generic War' Begins

Generic Launch Flood Following 'Posiga' Patent Expiry
Rapid Growth of SGLT-2 Inhibitors with Diverse Benefits

150 Generic Products Released... Fierce Competition in 'Combination Drugs'
Daewoong Bets on New Drug 'Enblojeong'

As the number of diabetes patients rapidly increases, the expiration of the patent for the popular drug 'Forxiga' (active ingredient dapagliflozin) has triggered a generic drug war among domestic companies. While some are focusing on developing 'combination drugs' to secure market dominance, others are betting on new drugs that improve medication convenience.

AstraZeneca's diabetes treatment 'Forxiga (active ingredient dapagliflozin)'
[Photo by Korea AstraZeneca]

According to the industry on the 11th, the patent for dapagliflozin, a sodium-glucose co-transporter (SGLT)-2 inhibitor, expired on the 7th. From the very next day, 149 diabetes treatments containing this ingredient (89 single agents and 60 combination drugs) were simultaneously listed on the reimbursement list. Including the two 'prodrugs' of Donga ST's 'Dapapro' already on the market, more than 150 diabetes drugs have begun a battle to secure market share.

SGLT-2 inhibitors work by suppressing glucose reabsorption and promoting its excretion through urine, thereby controlling blood sugar levels. Because they inhibit sugar absorption, they not only have a fundamental blood sugar-lowering effect but also offer significant benefits in weight reduction, and their excellent cardiovascular and renal safety profiles make them promising treatments for major diabetes complications such as heart failure and kidney disease. Leveraging these characteristics, the market has maintained an annual growth rate of about 10%, recording 172.3 billion KRW in outpatient prescription sales last year.

In response, HK Inno.N, which launched the generic 'Dapaen Tablet,' named its launch symposium 'Simshindangbu' (Heart, Kidney, Diabetes) and invited professors from endocrinology, family medicine, cardiology, and nephrology to emphasize various use cases of dapagliflozin. However, unlike the original Forxiga, which has indications for chronic heart failure and chronic kidney disease, generics have secured indications only for type 2 diabetes.

Especially this month, with the expansion of National Health Insurance reimbursement for combination therapies for diabetes treatment, competition to dominate the market has intensified. Diabetes treatment often involves combination therapy using multiple drugs to achieve better therapeutic effects rather than relying on a single medication. From this month, reimbursement has been applied to combination therapies involving two drugs with metformin and three-drug regimens including dipeptidyl peptidase (DPP)-4 inhibitors along with SGLT-2 inhibitors, raising expectations for market expansion.

LG Chem's diabetes treatment combination drug 'Zemidapa'
[Photo by LG Chem]

To secure market dominance, pharmaceutical companies have started developing combination drugs. Already, 60 combination drugs containing dapagliflozin, comparable in number to single agents, have been listed on the reimbursement list. Since patients undergoing combination therapy for diabetes often need to take two to three pills at once, and if they suffer from other chronic diseases, they must take those medications as well, the strategy is to enhance patient convenience by combining various ingredients into a single pill.

Last year, Daewon Pharmaceutical was the first to receive marketing approval for 'Dapacombi Tablet,' a combination with the DPP-4 inhibitor sitagliptin, and various combination drugs have since emerged. LG Chem launched 'Gemidapa Tablet,' based on its own developed drug gemigliptin, and is also developing a triple combination including metformin. Donga ST has obtained marketing approval for 'Sugadapa Tablet,' a combination with its own new drug evogliptin, aiming for a launch within the second quarter. However, unlike the reimbursement for combination therapies, the combination drugs with DPP-4 inhibitors have not yet completed the process for reimbursement application, and health insurance coverage is expected to begin as early as next month, leading to predictions that the real competition will start then.

Given the significant growth potential of the SGLT-2 inhibitor market, generic development is also active in preparation for patent expirations of other drugs. Boehringer Ingelheim's 'Jardiance' (active ingredient empagliflozin) is expected to lose its patent in 2025, but more than 100 generics have already received marketing approval.

Daewoong Pharmaceutical's SGLT-2 inhibitor mechanism diabetes treatment new drug 'Enblo Tablet' logo
[Photo by Daewoong Pharmaceutical]

Domestic new drugs are also rushing to market. Daewoong Pharmaceutical plans to launch the SGLT-2 inhibitor 'Enblo Tablet' (active ingredient inavogliflozin) within the first half of this year.

With other SGLT-2 inhibitors already dominating the market, Enblo's weapon is medication convenience. A Daewoong Pharmaceutical official explained, "It can achieve similar effects at one-thirtieth the dose of existing drugs, allowing the pill size to be reduced. One of the complaints from diabetes patients is having to take many medications together, so we expect to improve medication convenience." In fact, while the usual dose of other SGLT-2 inhibitors is 10 mg, Enblo Tablet's dose is about 0.3 mg. Combination drugs with other ingredients are currently undergoing clinical trials and will be launched alongside the single agent. Additionally, related development is underway to add indications for heart and kidney diseases.

This content was produced with the assistance of AI translation services.