Jardaince patent expires Oct 23…over 400 generics expected

Dongkoo contract-manufactures several generic drugs…will introduce an extended-release formulation of a drug for the first time

CKD and Daewon are launching the first type of empagliflozin + sitagliptin

Product photo of Jardiance

As the substance patent for Jardiance (empagliflozin, Boehringer), an SGLT2 inhibitor for the treatment of diabetes, is expiring next month (October 23), over 400 generic drugs are expected to be introduced to the market.

 

Notably, domestic pharmaceutical companies in Korea have developed empagliflozin + metformin extended-release tablets and are launching the first type of combination therapies, such as empagliflozin + sitagliptin.

 

They are expected to revitalize the sales market.

 

According to industry sources on September 14, Korean pharmaceutical companies announced the launch of Jardiance generic drugs next month and began pre-marketing.

 

Along with Forxiga, which was withdrawn from the Korean market, Jardiance is among the top two SGLT inhibitors for the treatment of diabetes.

 

Based on last year's UBSIT, outpatient prescription sales for Jardiance monotherapy amounted to KRW 66.3 billion and for Jardiance Duo (empagliflozin + metformin) recorded KRW 41.8 billion, accounting for a market exceeding KRW 100 billion.

 

Esgliteo, a combination of empagliflozin and linagliptin, also recorded KRW 12.1 billion and became a blockbuster drug.

 

Domestic pharmaceutical companies that seized the opportunity for the Forxiga patent expiration in April 2023 are also entering the Jardiance market, which is a KRW 100 billion market, with their generic drugs.

 

A total of 412 empagliflozin monotherapy and combination products have been approved so far.

 

Pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical are expected to receive higher prices by entering the generic drug market with their independently developed data-submission drugs.

 

Several generic products were developed before the implementation of the joint bioequivalence test regulation, which meant they could not meet the self-developed bioequivalence test conditions.

 

Among the generic monotherapies, only Dongkoo Bio & Pharma and Huons have met the requirements.

 

Consequently, Dongkoo Bio & Pharma, which contract-manufactures generic drugs for over 20 pharmaceutical companies, is expected to receive the highest price among generics due to the innovative pharmaceutical company premium.

 

With this premium, a cost of KRW 396 for the 10mg dose and KRW 518 for the 25mg dose is set, which corresponds to a 68% markup of the highest-priced drug.

 

Among the generic drugs for the empagliflozin + metformin combination, there is also an extended-release film-coated tablet formulation that is taken once daily.

 

The original product does not have an extended-release formulation.

 

Additionally, Chong Kun Dang and Daewon Pharmaceutical have developed combination therapies that combine empagliflozin with the DPP-4 inhibitor sitagliptin, which they will be the first to introduce to the Korean market.

 

An unprecedented level of competition is expected due to the entry of these generic drugs, which circumvented the joint bioequivalence test regulation.

 

In addition, there are also drugs from pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical, which have developed their products using in-house technology and new extended-release formulations.

 

Related to this, a fierce competition is anticipated to create new prescriptions, with pharmaceutical companies pursuing independent sales and numerous CSOs joining in, offering high commission rates.

 

In response, Boehringer Ingelheim, which holds the original Jardiance that recently succeeded in obtaining expanded reimbursement to cover chronic kidney disease, is expected to defend its existing accounts while also actively expanding into new ones for a year, during which it will be granted a 70% premium on the highest price.

 

Jardiance is co-promoted in Korea with Yuhan Corporation.