Generics of Jardiance expected to compete for KRW 100B mkt

The Jardiance patent expires in October…333 products expected to be launched

'Xeljanz' patent set to expire in November…the first generic version of JAK inhibitor is expected to launch

The priority sales period for generic 'Cetus' drugs will expire in October…follow-on drugs to be launched

Product photo of Jardiance

The substance patent for Jardiance (empagliflozin), a diabetes treatment generating annual sales of approximately KRW 100 billion, is set to expire this October.

 

Generic competition in the SGLT-2 inhibitor diabetes drug market is likely to heat up again.

 

Approximately 50 companies have already secured approvals for related generic products.

 

In November, the substance patent of Pfizer's oral autoimmune disease treatment, 'Xeljanz (tofacitinib),' will expire.

 

Thiswill be followed by the first generic launch for a drug in the Janus Kinase (JAK) inhibitors category, with over 60 generics poised to enter a market valued at approximately KRW 15 billion annually.

 

The priority sales period for 'Cetus (pranlukast)' generics, treatment for asthma and allergic rhinitis, will also end in October.

 

Therefore, generic drugs without this priority sales marketing authorization are expected to enter the market.

 

'Generic Jardiance' expected to launch in October...variable is the 'unlisted patent' According to the Ministry of Food and Drug Safety (MFDS), on June 30, Boehringer Ingelheim's Jardiance substance patent is set to expire on October 23.

 

The pharmaceutical industry anticipates a mass launch of generics around the time of the patent expiration.

 

Generic companies have successfully circumvented the remaining listed patents in their patent disputes with Boehringer Ingelheim, excluding the substance patent.

 

Currently, 49 companies have received product approvals for 333 empagliflozin-based single and fixed-dose combination products.

 

Specifically, 48 generic companies have obtained approval for 100 Jardiance generic products, while 36 companies have approval for 213 Jardiance Duo (empagliflozin + metformin) generic products.

 

For Esglito (empagliflozin + linagliptin) generics, five companies have obtained approval for 10 products.

 

Products with active ingredients or combinations not found in the original drug are also ready for launch.

 

Chong Kun Dang received approval for four follow-on products combining empagliflozin + sitagliptin, and and Daewon Pharm received approval for six follow-on products combining empagliflozin + sitagliptin + metformin.

 

Generic competition is expected to heat up again in the diabetes drug market.

 

Generic companies have signaled their entry into the empagliflozin market, which has grown to over KRW 100 billion annually.

 

According to pharmaceutical market research firm UBIST, the combined prescription sales of Jardiance and Jardiance Duo last year reached KRW 108.2 billion, an 11% increase from KRW 97.5 billion in 2023.

 

The withdrawal of Forxiga (dapagliflozin) from the market is analyzed to have significantly contributed to Jardiance's upward trend.

 

AstraZeneca decided to withdraw Forxiga from the Korean market at the end of 2023.

 

However, they retained Xigduo, a combination product containing metformin.

 

Forxiga was supplied domestically until the middle of last year.

 

Jardiance took over the KRW 50 billion market gap left by Forxiga.

 

Jardiance's prescription sales increased by 22% over the year, from KRW 15 billion in Q4 2023 to KRW 18.2 billion in Q4 2024.

 

In Q1 this year, it further increased to KRW 19 billion.

 

Additionally, Jardiance Duo, the metformin combination product, shows a steady upward trend.

 

In Q1 this year, it recorded KRW 10.8 billion in prescription sales, representing a 10% year-over-year (YoY) increase.

 

Given that annual prescription sales of Jardiance and Jardiance Duo totaled KRW 100 billion, challenges from generics are expected to be intense.

 

The variable lies in 'unlisted patents.' Boehringer Ingelheim Korea holds over nine patents related to Jardiance, Jardiance Duo, and Esglito that are registered with the Korean Intellectual Property Office (KIPO) but not listed in the MFDS patent registry.

 

While their absence from the listed patents does not affect product approval, there is a risk of patent infringement upon launch.

 

Boehringer Ingelheim Korea plans to enforce its patent rights vigorously.

 

In the case of Trajenta's (linagliptin) substance patent expiration last year, Boehringer Ingelheim Korea proactively warned generic companies about patent infringement by sending certified mail.

 

In response, generic companies are challenging the undisclosed Jardiance patents through avoidance or invalidation efforts.

 

The industry anticipates that a significant number of generic companies will proceed with their generic launches after the substance patent expires.

 

This is because many generic companies launched products with similar patent infringement risks when Trajenta's substance patent expired.

 

On November 22, Pfizer's Xeljanz patent will expire.

 

All eyes are on this because it is the patent expiration of one of the oral autoimmune disease treatments.

 

Fifty-five companies have received product approvals for 63 generic items.

 

These companies are set to challenge the KRW 14.4 billion Xeljanz market.

 

Furthermore, competition with other original JAK inhibitor drugs, including Xeljanz, is also expected.

 

JAK inhibitors, such as Xeljanz, Rinvoq (upadacitinib), Olumiant (baricitinib), and Jyseleca (filgotinib), have been launched in Korea.

 

Prescription sales for these drugs last year totaled KRW 62.2 billion, a 56% increase YoY.

 

Priority sales period for 'Cetus' with market worth KRW 46 billion annually, expires in October…more generics expected to enter

Product photo of Cetus

The priority sales period for generic Cetus, an asthma and allergic rhinitis treatment with annual sales of KRW 46 billion, will expire on October 1.

 

This will allow the launch of generics that did not receive priority sales rights.

 

Previously, generic companies filed a passive rights scope confirmation trial against Sam-A Pharm's Cetus formulation patent.

 

Subsequently, in October last year, they received a favorable judgment from the Intellectual Trial and Appeal Board.

 

This judgment was confirmed without an appeal from Sam-A Pharm.

 

Based on their first-instance victory, the challenging companies have successively obtained generic approvals.

 

Among these, Dasan Pharmaceutical's 'Prituss,' Dongkook Pharmaceutical's 'Pranpid,' Green Cross's 'Neofran,' and Daewoong Bio's 'Cituone' received priority sales rights.

 

The priority sales period runs from November last year to October this year.

 

Generic companies that did not receive priority sales rights during this period can launch their products after October.

 

The launch of follow-on generics from Hanwha Pharmaceutical and Dongkoo Bio is expected.

 

These companies have previously won patent disputes against Sam-A Pharm.

 

Hanwha Pharmaceutical has even obtained generic product approval under the name 'Citurien'.

 

Despite Cetus's annual prescription sales of KRW 46 billion, and the fact that earlier launched Cetus generics have not firmly established themselves in the asthma and allergic rhinitis treatment market, analysis suggests that follow-on drugs launching about a year later will still have significant competitiveness.

 

In Q1 this year, Cetus generics recorded only KRW 600 million in prescription sales, representing about a 5% market share in the overall pranlukast market.

 

In contrast, the original Cetus saw a slight increase to KRW 11.4 billion in Q1 this year compared to the same period last year.