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  • Generic for Xeljanz by Boryung was first approved
  • by Lee, Tak-Sun | translator Choi HeeYoung | Sep 1, 2020 06:12am
Failed to avoid patent for salt-modifying drugs
Failure to obtain generic exclusivity, available after November 22, 2025
 ¡ã 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
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