NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 8 pharmaceutical companies such as PF PRISM CV, PFIZER, AJANTA PHARMA LTD and others. It is marketed under 4 brand names, including XELJANZ, XELJANZ XR, TOFACITINIB CITRATE and others. Available in 5 different strengths, such as EQ 5MG BASE, EQ 11MG BASE, EQ 10MG BASE and others, and administered through 3 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;ORAL, SOLUTION;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"38548","ingredient":"TOFACITINIB CITRATE","trade_name":"XELJANZ","family_id":"18731909e253459d9997","publication_number":"USRE41783E","cleaned_patent_number":"RE41783","drug_product_flag":"-","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-08","publication_date":"2010-09-28","legal_status":"Expired - Lifetime"} | USRE41783E1 | 28 Sep, 2010 | Expired - Lifetime | 08 Jun, 2026 | |
| {"application_id":"34249","ingredient":"TOFACITINIB CITRATE","trade_name":"XELJANZ XR","family_id":"e2ae75e56c7f4112bb91","publication_number":"US10639309B2","cleaned_patent_number":"10639309","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-09-14","publication_date":"2020-05-05","legal_status":"Granted"} | US10639309B2 | 05 May, 2020 | Granted | 14 Sep, 2034 | |
| {"application_id":"34250","ingredient":"TOFACITINIB CITRATE","trade_name":"XELJANZ XR","family_id":"b2e07a7f037e485babf3","publication_number":"US11253523B2","cleaned_patent_number":"11253523","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-09-14","publication_date":"2022-02-22","legal_status":"Granted"} | US11253523B2 | 22 Feb, 2022 | Granted | 14 Sep, 2034 | |
| {"application_id":"1828","ingredient":"TOFACITINIB CITRATE","trade_name":"XELJANZ XR","family_id":"e2ae75e56c7f4112bb91","publication_number":"US9937181B2","cleaned_patent_number":"9937181","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-09-14","publication_date":"2018-04-10","legal_status":"Granted"} | US9937181B2 | 10 Apr, 2018 | Granted | 14 Sep, 2034 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.