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Last Updated: April 18, 2024

TOFACITINIB CITRATE - Generic Drug Details

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What are the generic sources for tofacitinib citrate and what is the scope of patent protection?

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

See all TOFACITINIB CITRATE clinical trials

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	10MG	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Slayback Pharma Llc	TOFACITINIB CITRATE	tofacitinib citrate	SOLUTION;ORAL	216878-001	Sep 25, 2023	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Ajanta Pharma Ltd	TOFACITINIB CITRATE	tofacitinib citrate	TABLET;ORAL	212943-001	Jun 1, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Micro Labs	TOFACITINIB CITRATE	tofacitinib citrate	TABLET;ORAL	209738-001	Mar 13, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TOFACITINIB CITRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019	⤷ Try a Trial	⤷ Try a Trial
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	⤷ Try a Trial	⤷ Try a Trial
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	⤷ Try a Trial	⤷ Try a Trial
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	⤷ Try a Trial	⤷ Try a Trial
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	⤷ Try a Trial	⤷ Try a Trial
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	⤷ Try a Trial	⤷ Try a Trial
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TOFACITINIB CITRATE

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Country	Patent Number	Title	Estimated Expiration
Canada	2905604	FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB A LIBERATION PROLONGEE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)	⤷ Try a Trial
South Korea	20200103892	토파시티닙 경구용 지속 방출 투여 형태 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)	⤷ Try a Trial
Honduras	2000000265	COMPUESTOS DE PIRROLO (2,3d) PIRIMIDINA	⤷ Try a Trial
African Regional IP Organization (ARIPO)	1905	Pyrrolo[2,3-d] Pyrimidine Compounds.	⤷ Try a Trial
Eurasian Patent Organization	006227	СОЕДИНЕНИЯ ПИРРОЛО[2,3-d]ПИРИМИДИНА (PIRROLO(2,3-d)PYRIMIDINE COMPOUNDS)	⤷ Try a Trial
Argentina	026534	COMPUESTOS DE PIRROLO[2,3-D]PIRIMIDINA, COMPOSICION FARMACEUTICA QUE LOS CONTIENE, SU USO COMO MEDICAMENTO, SU USO PARA LA MANUFACTURA DE UN MEDICAMENTO Y COMBINACION DE LOS MISMOS CON AGENTAS MODULADORES DEL SISTEMA INMUNE O ANTIINFLAMATORIO	⤷ Try a Trial
Denmark	1235830		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TOFACITINIB CITRATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	37/2017	Austria	⤷ Try a Trial	PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324
1235830	C01235830/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
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	2017C/032	Belgium	⤷ Try a Trial	PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481	1790038-2	Sweden	⤷ Try a Trial	PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REG. NO/DATE: EU/1/17/1178 20170324
1666481	C201730033	Spain	⤷ Try a Trial	PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.