Jardiance generics prepare for final launch in Korea

targets the market void caused by Forxiga’s market withdrawal

Companies seek to challenge Jardiance’s patent ahead of its product patent expiry in March

Last-minute generic approvals are in full swing... Companies plan to bear the risk of unregistered patents and launch their respective generics

Generic companies are in the midst of last-minute preparations to enter the market for the SGLT inhibitor diabetes drug Jardiance (empagliflozin), which is set to expire in just about half a year.

 

With Forxiga’s market withdrawal expected to leave an annual sales gap of KRW 50 billion, the race to fill this gap is expected to intensify among the generic companies.

 

Generic companies seek to avoid Jardiance’s crystalline form patent 8 years later…are they eyeing Forxiga’s gap?

 

According to industry sources on the 26th, Hanmi Pharmacuetical and KyungDong Pharm recently won the passive trial to confirm the scope of Jardiance’s crystalline form patent (10-1249711).

 

In the case of Hanmi Pharmaceutical, it succeeded in avoiding Jardiance’s crystalline patent a step later than other companies.

 

More than 50 companies, including Chong Kun Dang, have challenged Jardiance’s crystalline form patent since 2018 and won their first trial between 2019 to 2021.

 

Hanmi Pharmacuetical had also filed to invalidate the same Jardiance’s patent in 2015 but hadn’t made much action since losing the first trial the following year.

 

Even when the other companies filed a series of challenges to avoid the crystalline patent, Hanmi Pharmaceutical chose not to join in the race.

 

However, in March this year, the company changed its course and again filed to avoid the crystalline patent.

 

The company’s challenge comes 8 years later than the other companies.

 

Like the other companies, Hanmi Pharmaceutical plans to launch its generic early, when the patent for Jadian expires in March next year.

 

Some speculate that AstraZeneca’s decision to withdraw another SGLT-2 inhibitor, Forxiga, from South Korea, may have played a role in this.

 

AstraZeneca Korea decided to withdraw Forxiga from the Korean market last December.

 

Forxiga was the leading SGLT-2 inhibitor in the market until recently.

 

With the market leader withdrawing from the market, industry insiders believe that the generic companies are seeking to target this void created by the withdrawal.

 

In fact, prior to Hanmi Pharmaceutical, Daehwa Pharmaceutical, Medica Korea, Korea Prime Pharmaceutical, and Aprogen Biologics filed challenges to avoid the crystalline patent and launch their generic versions of Jardiance in March this year.

 

All of these challenges were filed after AstraZeneca decided to withdraw Forxiga from South Korea.

 

According to the market research institution UBIST, Forxiga’s prescription sales amounted to KRW 51 billion in 2022.

 

Last year, its prescriptions grew 9% to KRW 55.5 billion, despite the launch of its generics upon Forxiga’s patent expiry.

 

The rise in prescription sales was slightly slower this year, earning KRW 21.7 billion in the first half of the year.

 

In Q2, the drug’s sales were overtaken by the combined prescription volume of its generics.

 

As a result, the drug’s prescriptions are expected to decline in earnest in the second half of this year.

 

AstraZeneca Korea plans to supply Forxiga domestically only until the first half of this year, and then distribute only the stockpiled amount.

 

This means that from next year, a KRW 50 billion gap will remain unfilled in the market in earnest.

 

Last-minute generic approvals also in full swing...companies expected to push ahead with launch despite unregistered patent risk Due to such circumstances, the domestic pharmaceutical companies' expectations for Jardiance’s generic market have also been growing ahead of the expiration of the product patent.

 

Companies that have previously succeeded in avoiding Jardiance’s crystalline patent are in the midst of last-minute preparations, including receiving authorizations for their generics one after another.

 

Only this month, GC Cross and Dongkwang Pharm received approval for their generic versions of Jardiance and Jardiance Duo.

 

Including the two, there are now 53 companies that have authorized generic versions of Jardiance and Jardiance Duo.

 

If Hanmi Pharmaceutical and Daehwa Pharmaceutical, which succeeded in avoiding Jardiance’s crystalline patent, also receive approval for their respective generic versions, the number of approved generic companies is expected to increase to 60.

 

In other words, fierce competition among Jardiance generics is expected from March next year.

 

The product patent for Jardiance will expire in March next year.

 

Other than the product patent, the crystalline patent is the only patent registered in MFDS’s green list.

 

Generic companies plan to avoid the crystalline patent and release generics early in line with the date of Jardiance’s substance patent expiry.

 

Although there are still patents that have not been registered in Korea’s green list, most companies are expected to push ahead and launch their respective generics.

 

In the case of Trajenta generics, most companies pushed ahead with their generic launches without fully addressing the risk of its unlisted patents.