Generics challenge the patent of mkt leading 'Rinvoq'

Chong Kun Dang has filed an invalidation trial against AbbVie for Rinvoq's 'methods of manufacture patent'

Early generic launch expected after the substance patent expiration in 2032…more companies expected to join the filing trial

Rinvoq has solidified leading the market, taking 45% of the KRW 62 billion JAK inhibitor market

Product photo of Rinvoq

The patent challenges by generics targeting AbbVie's Janus kinase (JAK) inhibitor' Rinvoq (upadacitinib)' have begun.

 

The pharmaceutical industry anticipates that patent challenges will further expand as Rinvoq strengthens its monopolistic position in the JAK inhibitor market, which is valued at approximately KRW 62 billion annually.

 

Chong Kun Dang Files Invalidation Trial for Rinvoq's Methods of Manufacture…More Companies Expected to Join According to the pharmaceutical industry on the 20th, Chong Kun Dang filed a petition for trial to confirm the scope of rights against AbbVie on the 19th regarding Rinvoq's manufacturing method patent.

 

This is the first patent challenge against Rinvoq.

 

Rinvoq is a JAK inhibitor used to treat autoimmune diseases, including rheumatoid arthritis and atopic dermatitis.

 

Its mechanism of action inhibits the production of inflammatory cytokines, thereby blocking inflammation, pain, and cell activation.

 

After Xeljanz was launched in 2015, Olumiant and Rinvoq joined the competition in 2019 and 2021, respectively.

 

Cibinqo and Jyseleca joined in 2023.

 

Rinvoq has two registered patents: a substance patent expiring in May 2032 and a method of manufacture patent expiring in October 2036.

 

It is expected that companies will first circumvent the patent expiring in 2036 and then launch their generics early, around the time of the expiration of the substance patent in 2032.

 

The pharmaceutical industry expects that more companies will challenge Rinvoq's manufacturing method patent, following Chong Kun Dang.

 

This is because the JAK inhibitor market is experiencing rapid growth, and Rinvoq is strenthening its monopolistic position.

 

JAK Inhibitor

According to pharmaceutical market research firm UBIST, the outpatient prescription sales of JAK inhibitors in the first half of this year were KRW 38.6 billion.

 

This represents a 40% increase from the previous year, compared to KRW 27.5 billion in the first half of last year.

 

JAK inhibitors are showing rapid growth in the autoimmune disease treatment market, driven by the convenience of their oral formulation.

 

The JAK inhibitor market, which was KRW 18.7 billion in 2020, grew by 36% to KRW 25.5 billion the following year.

 

The market size expanded with the addition of Rinvoq in 2021.

 

Subsequently, it grew significantly each year, reaching KRW 35.5 billion in 2022, KRW 40 billion in 2023, and KRW 62.2 billion in 2024.

 

During this period, the reimbursement expansion of key products drove market growth.

 

An analysis suggests that the growth rate accelerated further after October 2024, when inter-class switching between JAK inhibitors for rheumatoid arthritis was approved for reimbursement.

 

Rinvoq Strengthens Market Monopoly…H1 Market Share at 43% While the market has expanded, Rinvoq has further strengthened its monopolistic position.

 

In the first half of this year, Rinvoq's prescription sales reached KRW 16.7 billion, a 49% increase from KRW 11.2 billion in the same period last year.

 

Although prescription sales for other major JAK inhibitors also increased, their growth was not as rapid as Rinvoq's.

 

Olumiant, the second-leading product in the market, saw a 26% increase from KRW 8 billion in the first half of last year to KRW 10.1 billion in the first half of this year.

 

Xeljanz grew by 3% from KRW 6.9 billion to KRW 7.1 billion.

 

Cibinqo and Jyseleca recorded prescription sales of KRW 3.2 billion and KRW 1.6 billion, respectively, in the first half of this year.

 

As of the first half of this year, Rinvoq's market share in the JAK inhibitor market reached 43%.

 

Compared to its 19% market share in the first half of 2022, this represents a 24 percentage point increase in three years.

 

At the same time, Rinvoq, which was the third-largest player after Olumiant and Xeljanz, rose to the top spot in the market from the first half of 2024.

 

Quarterly Sales Performance of Major JAK Inhibitors (unit: KRW 100 million, source: UBIST).

 

GREEN-Rinvoq, SKY BLUE-Olumiant, BLUE-Xeljanz

The rapid increase in Rinvoq's prescription sales is attributed to its having the most indications in Korea.

 

Rinvoq holds indications for: ▲rheumatoid arthritis ▲psoriatic arthritis ▲ankylosing spondylitis ▲atopic dermatitis (adults and adolescents aged 12 and older) ▲ulcerative colitis and ▲Crohn's disease.

 

Competing drug Olumiant has indications for: ▲rheumatoid arthritis ▲atopic dermatitis (adults and children aged 2 and older) ▲alopecia areata and ▲polyarticular juvenile idiopathic arthritis (pJIA).

 

Xeljanz has indications for: ▲rheumatoid arthritis ▲psoriatic arthritis and ▲ankylosing spondylitis.

 

Cibinqo has secured an indication for atopic dermatitis in adults and adolescents aged 12 and older, while Jyseleca has indications for rheumatoid arthritis and ulcerative colitis.

 

A variable in this market is the launch of Xeljanz generics.

 

The Xeljanz substance patent is set to expire in November this year.

 

The crystal form patent, which expires in 2027, has been overcome by generic companies through numerous invalidation and circumvention trials.

 

This means that Xeljanz generics are expected to launch all at once after November this year.

 

Currently, 58 companies have obtained product approvals for 67 generic items and are ready for launch.

 

Xeljanz generics are expected to be launched simultaneously without priority sales rights.

 

This is because generic companies' victories in invalidation trials led to the deletion of the listed patents, making it impossible to acquire priority sales rights.