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XELJANZ Drug Profile

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Which patents cover Xeljanz, and when can generic versions of Xeljanz launch?

Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nine patent family members in fifty-four countries.

The generic ingredient in XELJANZ is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xeljanz

Xeljanz was eligible for patent challenges on November 6, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2025. This may change due to patent challenges or generic licensing.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XELJANZ

International Patents:	109
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	21
Patent Applications:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XELJANZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELJANZ
What excipients (inactive ingredients) are in XELJANZ?	XELJANZ excipients list
DailyMed Link:	XELJANZ at DailyMed

See drug prices for XELJANZ

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for XELJANZ

NDA:

203214

Dosage:

TABLET;ORAL

NDA:

213082

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XELJANZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
TWi Biotechnology, Inc.	Phase 1
University of Erlangen-Nürnberg Medical School	Phase 3

See all XELJANZ clinical trials

Pharmacology for XELJANZ

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

ATC Classes for XELJANZ

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

Paragraph IV (Patent) Challenges for XELJANZ

Tradename	Dosage	Ingredient	NDA	Submissiondate
XELJANZ	TABLET;ORAL	tofacitinib citrate	203214	2016-11-07

US Patents and Regulatory Information for XELJANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No				Y

Expired US Patents for XELJANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020

International Patents for XELJANZ

Country	Patent Number	Estimated Expiration
Turkey	200201498
Taiwan	200413370
European Patent Office	1609781
Turkey	200400105

Supplementary Protection Certificates for XELJANZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2017 00035	Denmark		PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 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