Chia Tai Tianqing succeeded in the patent challenge, and the core patent—compound patent of Pfizer’s JAK inhibitor tofacitinib was fully declared invalid in China.
Tofacitinib—the JAK inhibitor with efficacy comparable to the "drug king" Humira
Tofacitinib Citrate (trade name: Xeljanz) is an oral inhibitor targeting JAK3 and JAK1 developed by Pfizer, the first JAK inhibitor approved by FDA to treat rheumatoid arthritis (RA), and also the first oral disease-modifying antirheumatic drug (DMARD) approved to treat RA in recent decade, of which the efficacy is considered to be comparable to the "drug king" Humira by insiders. Its approval process is as follows:
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November 6, 2012 |
Approved by FDA for marketing, with trade name: Xeljanz, approved specification: 5mg, dosage form: tablet, used to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, being the first oral JAK inhibitor approved to treat RA |
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March 16, 2017 |
Approved by CFDA for marketing, with trade name: Xeljanz, approved specification: 5mg, dosage form: tablet, used to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, may be used in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). |
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February 23, 2016 |
Extended-release preparation approved by FDA for marketing, with trade name: Xeljanz XR, approved specification: 11mg, dosage form: tablet, indications same as Xeljanz, being the first once-daily oral RA drug approved for marketing |
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August 1, 2018 |
Approved by EMA, to treat adult patients with moderately to severely active ulcerative colitis (UC) |
(Source: Official websites of CFDA, FDA, and EMA)
Tofacitinib has so far been approved for marketing in over 80 countries; besides the indications of RA and UC, other indications such as psoriatic arthritis (PsA) and ankylosing spondylitis (AS) will be approved soon, and the clinical trials of its indications like Crohn's disease and alopecia areata have entered the mid- to late-stage clinical trials.
Patent application situation in China
Tofacitinib has been applied for many patents in China, and its patent declared invalid this time is the compound patent with application publication No. of CN1409712A. Its patent application situation in China is as follows:









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