Korean pharmaceutical companies have been obtaining approval for a generic version of Jardiance (empagliflozin), a drug that inhibits sodium-glucose co-transporter-2 (SGLT-2).
On Wednesday, the Ministry of Food and Drug Safety, formerly known as the Korea Food & Drug Administration, approved Chong Kun Dang’s empagliflozin 10mg and empagliflozin 25mg for the treatment of type 2 diabetes.
The ministry’s move is considered an early preparation to secure the generic market of Jardiance when the patent expires in 2025.
So far, 50 Korean pharmaceutical companies, including Chong Jun Dang, have obtained approval for generic Jardiance.
German pharmaceutical company Boehringer Ingelheim is the manufacturer of brand Jardiance.
Empagliflozin is recommended for the treatment of type 2 diabetes in adults, in association with diet and exercise therapy.
Earlier this year, other Korean drug companies such Dongkoo Bio & Pharma and Kukje Pharma received the first approval for generic Jardiance.
Chong Kun Dang has become the 50th company to get the approval of generic Jardiance in South Korea.
All drugmakers got the license for two doses of empagliflozin (10mg and 25 mg). Chong Kun Dang said its generic version of Jardiance is different because it has a modified solvate.
One of the two patents of brand Jardiance registered in Korea expires on October 23, 2025, while the other is expected to expire on December 14, 2026.
Local pharma companies will be able to sell generic versions of Jardiance from October 23, 2025, when the substance patent of Jardiance expires.
Why Korea is issuing generic approval four years before the patent expiration? That’s because the companies can avoid the agency’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,” according to Korean Bio-Med.
“Industry watchers said that domestic companies avoided the 1+3 restriction,” it added. “They are likely to face severe competition to sell their Jardiance generic drugs.”
