XELJANZ XR Drug Patent Profile

When do Xeljanz Xr patents expire, and what generic alternatives are available?

Xeljanz Xr is a drug marketed by Pfizer and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fifty-three patent family members in fifty-five countries.

The generic ingredient in XELJANZ XR 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 Xr

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

There have been twenty-one 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.

There is one tentative approval for the generic drug (tofacitinib citrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XELJANZ XR

International Patents:	153
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	28
Patent Applications:	151
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XELJANZ XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELJANZ XR
DailyMed Link:	XELJANZ XR at DailyMed

See drug prices for XELJANZ XR

Recent Clinical Trials for XELJANZ XR

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

Sponsor	Phase
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 4
University of Nebraska	Phase 4
Novartis	Phase 4

See all XELJANZ XR clinical trials

Pharmacology for XELJANZ XR

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for XELJANZ XR

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

Paragraph IV (Patent) Challenges for XELJANZ XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XELJANZ XR	Extended-release Tablets	tofacitinib citrate	22 mg	208246	1	2020-12-28
XELJANZ XR	Extended-release Tablets	tofacitinib citrate	11 mg	208246	1	2016-11-07

US Patents and Regulatory Information for XELJANZ XR

XELJANZ XR is protected by eight US patents and one FDA Regulatory Exclusivity.

Patents protecting XELJANZ XR

FDA Regulatory Exclusivity protecting XELJANZ XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		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 XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016

International Patents for XELJANZ XR

When does loss-of-exclusivity occur for XELJANZ XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XELJANZ XR around the world.

Country	Patent Number	Title	Estimated Expiration
Tunisia	SN03128	RESOLUTION OPTIQUE DE LA (1-BENZYL-4-METHYLPIPERIDINE-3-YL) METHYLAMINE ET SON UTILISATION POUR LA PREPARATION DE DERIVES DE PYRROLO 2,3-PYRIMIDINE SERVANT D'INHIBITEURS DE PROTEINES KINASES
Austria	257157
Taiwan	200300690
Canada	2178752	COMPOSITIONS DE PROTEINES AYANT SUBI UNE MODIFICATION CHIMIQUE A L'EXTREMITE N-TERMINALE ET PROCEDES (N-TERMINALLY CHEMICALLY MODIFIED PROTEIN COMPOSITIONS AND METHODS)
Czech Republic	20021846
Brazil	0209246

Supplementary Protection Certificates for XELJANZ XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	PA2017025,C1666481	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
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
0733067	5/2003	Austria		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
0733067	SPC/GB03/006	United Kingdom		PRODUCT NAME: PEGFILGRASTIM, AN N-TERMINALLY MONOPEGYLATED G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR); REGISTERED: UK EU/1/02/228/001 20020826; UK EU/1/02/227/001 20020826
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
0733067	SPC033/2002	Ireland		SPC033/2002: 20050111, EXPIRES: 20170821