Generics for Xeljanz are being approved one after another

Only Product Patents are valid after invalidation of Crystalline Form Patent, 31 companies approved since December last year

Generics can be released after product patent expiration in 2025

Xeljanz

Generics for Xeljanz (Tofacitinib) are being approved one after another.

 

After crystalline form patent was deleted from the list, it seems that domestic companies are competitively receiving generic licenses.

 

According to the MFDS on the 9th, until this day, a total of 42 generics for Xeljanz have been licensed.

 

Since Boryung's generic was first approved in August of last year, it has continued steadily.

 

Generics have increased rapidly since last December.

 

After GL Pharma on December 23, in about a month or two, 31 companies were granted generic licenses.

 

About half of these are companies that commissioned production to Boryung.

 

Boryung plans to consign products from 16 companies including Korea Prime at Ansan Plant 1.

 

Xeljanz has product patent that expires in November 2025 and crystalline form patent that expires in November 2027.

 

Many domestic companies have challenged the patent.

 

The challenge for crystalline form patent developed in two tracks.

 

20 companies, mainly Chong Kun Dang, requested an invalidation trial, and 16 companies, including Boryung, requested a passive trial to confirm the scope of rights.

 

In January 2018, as a result of a trial for the passive scope of rights, generics succeeded in evading patent for Xeljanz.

 

The result of the invalidation trial was also won by generics in November 2019.

 

This decision was confirmed in January 2020.

 

Following the decision of invalidation, crystalline form patent for Gelzanz was deleted in March last year.

 

The barrier to the Crystalline Form Patent, which expires in November 2027, has disappeared.

 

Companies that have succeeded in developing generics will be able to release generics after November 2025, when the product patent expires.

 

Considering that there are more than four years left until the expiration of the product patent, there is a high possibility that generic licenses from other pharmaceutical companies will be added.

 

Xeljanz is a JAK inhibitor family of autoimmune diseases.

 

It is released as an oral preparation in the autoimmune disease treatment market, which is mostly an injection, and has overcome the limitations of existing TNF alpha inhibitors.

 

According to UBIST, the amount of outpatient prescriptions last year was ₩12.6 billion.

 

Since its launch in the domestic market in July 2015, Xeljanz has rapidly increased its prescription performance to ₩1.7 billion in 2016, ₩3.3 billion in 2017, ₩8.3 billion in 2018, and ₩12.6 billion in 2019.

 

However, compared to 2019, in 2020, it was stagnant, and this is analyzed due to the addition of Olumiant (Baricitinib) from Lilly.

 

And, no domestic companies have challenged patent of Olumiant.