Generic for Xeljanz by Boryung was first approved

Failed to avoid patent for salt-modifying drugs

Failure to obtain generic exclusivity, available after November 22, 2025

Pfizer

Boryeong's generic for Xeljanz was first approved.

 

On the 27th, the MFDS granted Boryung Tofacitinib 5mg (Tofacitinib aspartate) by Boryung as a drug for data-based re-evaluation.

 

This product is a salt-modified product of the original product Gelzanz 5mg (Tofacitinib citrate), which was approved in April 2014, and is the first approved product among generics using Tofacitinib as an active ingredient.

 

This product is expected to be available from November 23, 2025, when the materical patent ends.

 

If the patent challenge had been successful as originally planned, it could be released from November 24th.

 

The Intellectual Property Appeal Board ruled that the avoidance of extending the duration of a material patent through a salt-modifying drug was established in January 2018.

 

The lawsuit was terminated due to the deprivation of generics, when the Supreme Court ruled that patent evasion was impossible in Vesicare’s salt change case.

 

If it had avoided the extension of the duration of the material patent, it could be released on November 24 this year.

 

It is the first drug for generics, but it is also impossible to obtain generic exclusivity.

 

Boryung succeeded in evading the crystalline patent ending on November 24, 2027, but the patent was deleted on March 2 of this year due to the winning of Chong Kun Dang's patent invalidation trial.

 

Because there was no registered patent before applying for permission, it became impossible to obtain generic exclusivity.

 

Approval for generic release was possible after the expiration of the PMS on April 1.

 

Accordingly, efforts to challenge patents to obtain generic exclusivity and early release were useless.

 

It only worked to get rid of the crystalline patent.

 

However, with the deletion of the patent list, the benefits of successful patent challenge companies have disappeared.

 

Xeljanz is the first oral drug to be released on the market for rheumatoid arthritis drugs, mostly in the form of injections.

 

Based on IQVIA, last year’s sales amounted to ₩14.7 billion, a 55.4% increase from the previous year.

 

It is very unfortunate that the early release due to the patent challenge is unsuccessful as a generic.