Jardiance generics win approvals one after another

Kukje, Dongkoo and Prime can release generics after product patent expiration in October 2025

52 companies evading crystalline form patent expiring in 2026 highly likely to seek for approval

A series of generics of Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin) seem to be receiving the market authorization one after another.

 

On Mar.

 

3, South Korea’s Ministry of Food and Drug Safety (MFDS) authorized Korea Prime Pharm’s Empazin 10 mg and 20 mg tablets.

 

As a result, three South Korean companies—Kukje Pharma, Dongkoo Bio & Pharma and Korea Prime Pharm—have Jardiance generics ready for the market.

 

The health authority green lit Kukje Pharma and Dongkoo Bio & Pharma’s Jardiance generics, Glinace and Empance, on Feb.

 

24.

 

These were the first Jardiance generics to be approved in the country.

 

Jardiance can be administered as a supplementary to diet and exercise therapies for adult patients with type 2 diabetes to control their blood sugar level.

 

Although the three items have been cleared for marketing, the Jardiance generic cannot be released immediately.

 

The product patent in Jardiance expiring in 2025 has not been challenged successfully.

 

In other words, the approved companies have presumably submitted a patent certification to MFDS that they agree to launch the products after October 2025, when Jardiance patent expires.

 

A company releasing the generic before the patent expiration would be penalized and lose the authorization.

 

The patent expiring on Oct.

 

23, 2025, ‘the use of and production of glucopyranosyl-substituted benzol derivatives and drug containing the compound,’ has been challenged by Dong-A ST attempting to nullify the patent in 2015, but it was eventually dismissed in 2018.

 

However, 52 South Korean pharmaceutical companies have successfully requested negative confirmation and evaded Jardiance’ crystalline form patent expiring in 2026.

 

Ultimately, the generic makers can either nullify the other patent, or launch the generics after Oct.

 

23, 2025 after the patent expiration.

 

Similar to Kukje Pharma, Dongkoo Bio & Pharma and Korea Prime Pharm, the other patent-evaded companies would highly likely to seek for the marketing authorization in advance.

 

Pharmaceutical market research data UBIST on outpatient prescription volume found Jardiance has generated 29.2 billion won and 35.4 billion won in 2019 and 2020, respectively.