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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:	5
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
TWi Biotechnology, Inc.	Phase 1
Hanlim Pharm. Co., Ltd.	Phase 1
Pfizer	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

Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
XELJANZ	TABLET;ORAL	tofacitinib citrate	203214	2016-11-07
XELJANZ XR	TABLET, EXTENDED RELEASE;ORAL	tofacitinib citrate	208246	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				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	AB	RX	Yes	Yes				Y
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No			Y

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	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018

International Patents for tofacitinib citrate

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	006227
Taiwan	I248935
South Korea	20150131238
Russian Federation	2315052
South Korea	20050044691

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	2017/036	Ireland		PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REGISTRATION NO/DATE: EU/1/17/1178/001 EU/1/17/1178/004 20170322
1666481	300887	Netherlands		PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1666481	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	C201730033	Spain		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