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The current US prescribing information for tofacitinib specifies that tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on these limited clinical data, unintentional exposure to tofacitinib during conception/pregnancy does not appear to be associated with an increased risk to the fetus when compared with risks identified in the general population and specifically reported in RA and psoriasis patients.","Geriatric use":"text","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=tofacitinib-xeljanz","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:36:49.518577+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:36:56.207781+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:36:49.539184+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tofacitinib-xeljanz","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:36:57.017868+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Janus Kinase (JAK) inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:36:57.705892+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2103743/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:36:57.611950+00:00"}},"allNames":"tofacitinib (xeljanz)","offLabel":[],"timeline":[],"aiSummary":"Tofacitinib (Xeljanz) is a medication developed by Pfizer Inc. 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Pfizer's XELJANZ® (tofacitinib) for the ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_fda_approval_of_xeljanz_xr_tofacitinib_citrate_extended_release_tablets_the_first_and_only_once_daily_oral_jak_inhibitor_treatment_for_rheumatoid_arthritis","date":"2026-04-07","type":"news","title":"Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate ...","source":"www.pfizer.com"}],"manufacturing":[],"molecularData":{"oral":true,"chemblId":"CHEMBL2103743","moleculeType":"Small molecule","molecularWeight":"504.50"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL2103743"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"_revenueScrapedAt":"2026-04-01 10:46:09.497268+00","biosimilarFilings":[],"commercialAnalysis":{"text":"Tofacitinib (Xeljanz) by Pfizer is a leading small molecule inhibitor of janus kinases (JAKs), with a strong presence in the treatment of rheumatoid arthritis, psoriatic arthritis, and other autoimmune diseases. As of 2025, the tofacitinib market size has grown to $3.08 billion, with a compound annual growth rate (CAGR) of 10.9% [1, Research and Markets, 2025]. The revenue is expected to reach $5.67 billion in 2029 at a CAGR of 13.5% [2, Research and Markets, 2025]. In 2023, the revenue of Xeljanz was $1087 million [3, Data Insights Market, 2026].\n\nThe competitive landscape of tofacitinib is dominated by Pfizer, with a significant market share. However, the market is expected to face threats from emerging competitors, such as upadacitinib and baricitinib, which are also JAK inhibitors [4, Cognitive Market Research, 2026]. The patent cliff for Xeljanz is expected to occur in 2029, which may lead to a decline in revenue [5, Research and Markets, 2025]. On the other hand, label expansions and pipeline competitors may provide growth opportunities for the market.\n\nKey upcoming catalysts for the tofacitinib market include the potential approval of new indications, such as atopic dermatitis, and the launch of pipeline competitors [6, Cognitive Market Research, 2026]. Additionally, market access initiatives and real-world evidence may also contribute to the growth of the market. Overall, the tofacitinib market is expected to experience significant growth in the next few years, driven by expanding indications and market access initiatives.\n\nIn conclusion, the tofacitinib market is a rapidly growing market, driven by the increasing incidence of autoimmune diseases and the clinical efficacy of tofacitinib. However, the market is expected to face threats from emerging competitors and patent cliffs.","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.datainsightsmarket.com/reports/xeljanz-tofacitnib-drug-1184658","date":"","title":"Consumer Trends in Xeljanz (tofacitnib) Drug Market 2026-2034","source":"www.datainsightsmarket.com"},{"url":"https://www.cognitivemarketresearch.com/xeljanz-tofacitnib-drug-market-report","date":"","title":"Xeljanz tofacitnib Drug Market Analysis 2026","source":"www.cognitivemarketresearch.com"},{"url":"https://www.researchandmarkets.com/report/tofacitinib?srsltid=AfmBOooAYgm5cdHhRAS-ufe6bbJ0oarkYU0-BTrv-bfb-FaynHP_glq4","date":"","title":"Tofacitinib Market Size, Competitors & Forecast to 2030","source":"www.researchandmarkets.com"}],"disclaimer":"AI-generated analysis based on public sources. 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