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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 Pfizer, Zydus Pharms, Ajanta Pharma Ltd, and Pf Prism Cv, and is included in five 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 fifty-two 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 is one tentative approval for this compound.

Summary for tofacitinib citrate

International Patents:	152
US Patents:	4
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	6
Patent Applications:	25
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
Rho Federal Systems Division, Inc.	Phase 1
Autoimmunity Centers of Excellence	Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1

See all tofacitinib citrate clinical trials

Generic filers with tentative approvals for TOFACITINIB CITRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 10MG BASE	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

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
XELJANZ XR	TABLET, EXTENDED RELEASE;ORAL	tofacitinib citrate	208246	2016-11-07
XELJANZ	TABLET;ORAL	tofacitinib citrate	203214	2016-11-07

US Patents and Regulatory Information for tofacitinib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No
Zydus Pharms	TOFACITINIB	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	214264-002	Aug 19, 2021	AB	RX	No	No

Expired US Patents for tofacitinib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016

International Patents for tofacitinib citrate

Country	Patent Number	Estimated Expiration
Taiwan	I264305
Cyprus	1111311
Denmark	2968155
Panama	8560201

Supplementary Protection Certificates for tofacitinib citrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	17C1031	France		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	132017000095300	Italy		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	C 2017 029	Romania		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	PA2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322