Patent suits active to release Rinvoq generics

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Following Chong Kun Dang, Daewoong Pharmaceutical also files passive scope confirmation trial

Additional trials likely to follow for first generic exclusivity rights

Generic competition inevitable ahead of 2032 substance patent expiry

Pic of Rinvoq

The race to launch generics of AbbVie’s Rinvoq (upadacitinib), an oral treatment for autoimmune diseases, is showing signs of intensifying patent disputes.

 

With the JAK inhibitor market expanding rapidly and Rinvoq solidifying its dominance, multiple companies are expected to mount patent challenges.

 

According to industry sources on the 1st, Daewoong Pharmaceutical recently filed a passive scope confirmation trial against AbbVie, challenging the crystalline form patent of Rinvoq.

 

Currently, two patents related to Rinvoq are registered: a substance patent expiring in May 2032 and a crystalline form patent expiring in October 2036.

 

Daewoong's strategy is to first circumvent the crystalline form patent and then launch a generic version early, timed for the expiration of the substance patent.

 

Chong Kun Dang opened the door to this dispute by challenging Rinvoq’s patents before Daewoong Pharmaceutical.

 

Chong Kun Dang filed a related trial request on the 19th of last month.

 

The pharmaceutical industry expects more companies to challenge Rinvoq’s patents from here on.

 

One of the key requirements for obtaining first generic exclusivity is filing the initial invalidation trial.

 

However, if another company files the same trial within 14 business days of the first filing date, it is also deemed to meet this requirement.

 

This is why additional trial filings are expected in the coming weeks as companies move to secure first generic exclusivity for Rinvoq.

 

According to UBIST, a pharmaceutical market research institution, outpatient prescriptions of JAK inhibitors in the first half of this year reached KRW 38.6 billion, up 40% from the KRW 27.5 billion in the same period last year.

 

JAK inhibitors are experiencing rapid growth in the autoimmune disease treatment market, driven by the convenience of being oral formulations.

 

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

 

It continued to grow significantly each year: KRW 35.5 billion in 2022, KRW 40 billion in 2023, and KRW 62.2 billion in 2024.

 

The expanded reimbursement granted for key products drove this market growth.

 

Growth accelerated further last October when switching between JAK inhibitors for rheumatoid arthritis was allowed reimbursement.

 

Major JAKi Prescriptions (AbbVie

During this market expansion, Rinvoq has tightened its grip as the dominant player.

 

In the first half of this year, Rinvoq recorded KRW 16.7 billion in prescriptions, a 49% increase from KRW 11.2 billion in the same period last year.

 

Its growth has outpaced competitors such as Xeljanz (tofacitinib) and Olumiant (baricitinib).

 

Having claimed the number one position in Q4 2023, Rinvoq has since expanded its market share, which now stands at 43% in the first half of this year.

 

Rinvoq is a JAK inhibitor used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis.

 

Its mechanism involves inhibiting inflammatory cytokines, thereby suppressing inflammation, pain, and cell activation.