Tofacitinib citrate - Generic Drug Details
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What are the generic sources for tofacitinib citrate and what is the scope of freedom to operate?
Tofacitinib citrate
is the generic ingredient in four branded drugs marketed by Slayback Pharma Llc, Pfizer, Zydus Pharms, Ajanta Pharma Ltd, Micro Labs, and Pf Prism Cv, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tofacitinib citrate has one hundred and twenty-three patent family members in fifty-five countries.
There are twelve drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for tofacitinib citrate
International Patents: | 123 |
US Patents: | 4 |
Tradenames: | 4 |
Applicants: | 6 |
NDAs: | 8 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 9 |
Patent Applications: | 281 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tofacitinib citrate |
DailyMed Link: | tofacitinib citrate at DailyMed |
Recent Clinical Trials for tofacitinib citrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
China-Japan Friendship Hospital | Phase 4 |
CAGE Bio Inc. | Phase 1/Phase 2 |
Pi Research Consultancy Center, Bangladesh | Early Phase 1 |
Generic filers with tentative approvals for TOFACITINIB CITRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 5MG BASE | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | EQ 10MG BASE | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for tofacitinib citrate
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for tofacitinib citrate
Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XELJANZ | Oral Solution | tofacitinib citrate | 1 mg/mL | 213082 | 1 | 2021-11-12 |
XELJANZ XR | Extended-release Tablets | tofacitinib citrate | 22 mg | 208246 | 1 | 2020-12-28 |
XELJANZ | Tablets | tofacitinib citrate | 10 mg | 203214 | 1 | 2019-07-24 |
XELJANZ | Tablets | tofacitinib citrate | 5 mg | 203214 | 3 | 2016-11-07 |
XELJANZ XR | Extended-release Tablets | tofacitinib citrate | 11 mg | 208246 | 1 | 2016-11-07 |
US Patents and Regulatory Information for tofacitinib citrate
Expired US Patents for tofacitinib citrate
International Patents for tofacitinib citrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 149616 | PYRROLO[2,3-d]PYRIMIDINE COMPOUNDS | ⤷ Try a Trial |
Russian Federation | 2018129861 | ОРАЛЬНЫЕ ДОЗИРОВАННЫЕ ФОРМЫ ТОФАЦИТИНИБА С НЕПРЕРЫВНЫМ ВЫСВОБОЖДЕНИЕМ | ⤷ Try a Trial |
Austria | 257157 | ⤷ Try a Trial | |
Honduras | 2000000265 | COMPUESTOS DE PIRROLO (2,3d) PIRIMIDINA | ⤷ Try a Trial |
Eurasian Patent Organization | 200200506 | ⤷ Try a Trial | |
Russian Federation | 2674345 | ОРАЛЬНЫЕ ДОЗИРОВАННЫЕ ФОРМЫ ТОФАЦИТИНИБА С НЕПРЕРЫВНЫМ ВЫСВОБОЖДЕНИЕМ (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS) | ⤷ Try a Trial |
European Patent Office | 1382339 | Compositions contenant des dérivés de pyrrolo 2,3-d pyrimidine (Compositions containing pyrrolo 2,3-d pyrimidine derivatives) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tofacitinib citrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1235830 | C01235830/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013 |
1666481 | 17C1031 | France | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
1666481 | C 2017 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA CITRAT 3-((3R,4R)-4-METIL-3-{METIL-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-AMINO]PERIDINIL)-3-OXO-PROPIONITRIL; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF NATIONAL AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322 |
1666481 | 132017000095300 | Italy | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRENDENTE IL SALE CITRATO(XELJANZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1178/001-004, 20170324 |
1666481 | LUC00031 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE CITRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
1666481 | 122017000062 | Germany | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
1666481 | CR 2017 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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