Local pharmaceutical companies are obtaining the marketing approval for generic copies of Jardiance, an antidiabetic SGLT-2 inhibitor, one after another. The move is regarded as an early preparation to secure the Jardiance generic market when the patent of Jardiance expires in 2025.

On Wednesday, the Ministry of Food and Drug Safety authorized Chong Kun Dang Empagliflozin Tab. 10mg (empagliflozin L-proline) and Empagliflozin Tab.25mg.

Fifty Korean drug companies have obtained approval for generic copies of Jardiance, Boehringer Ingelheim’s SGLT-2 inhibitor for the treatment of type-2 diabetes.
Fifty Korean drug companies have obtained approval for generic copies of Jardiance, Boehringer Ingelheim’s SGLT-2 inhibitor for the treatment of type-2 diabetes.

The treatment is indicated as an adjuvant to diet and exercise therapy to improve blood sugar control in adults with type-2 diabetes.

The original drug, Jardiance, was developed by Boehringer Ingelheim as an SGLT-2 inhibitor. Out of the 121.4 billion won ($103.5 million) outpatient prescriptions of SGLT-2 inhibitors in 2020, Jardiance took up 35.3 billion won, indicating that the Jardiance generic market is attractive to domestic drugmakers.

In February, other local pharmaceutical companies followed suit after Dongkoo Bio & Pharma. Kukje Pharma received the first approval for Jardiance generic drugs.

Chong Kun Dang has become the 50th company to get a Jardiance generic medicine approval in Korea.

As each drugmaker got the license for two doses, 10mg, and 25 mg, the number of Jardiance drugs reached 100. However, the company said that Chong Kun Dang Empagliflozine Tab. is different because it has a modified solvate.

Still, it will take some time for Jardiance generic drugs to compete in the market.

One of the two patents of Jardiance registered in Korea, “Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof,” expires on Oct. 23, 2025.

The other patent of Jardiance is expected to expire on Dec. 14, 2026. Still, a majority of the Korean generic drug companies could avoid the patent successfully.

Thus, local drugmakers will be able to release Jardiance generic copies on Oct. 23, 2025, when the substance patent of Jardiance expires.

Local drug companies obtained approval for generics four years before an expected market release, probably because they had to avoid the regulator’s so-called “bioequivalence 1+3 restriction” regulation. They applied for marketing approval before the regulator executed the regulation limiting the number of generic drugs that can receive approval with a single bioequivalence test data to a maximum of four.

Industry watchers said that domestic companies avoided the 1+3 restriction. They are likely to face severe competition to sell their Jardiance generic drugs.

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