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XELJANZ XR Drug Profile

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

Xeljanz Xr is a drug marketed by Pfizer Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-one patent family members in sixty 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.

US ANDA Litigation and Generic Entry Outlook for Xeljanz Xr

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

There have been thirteen 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 XR

International Patents:	221
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	67
Clinical Trials:	16
Patent Applications:	19
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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2
University of Colorado, Denver	Phase 2
Göteborg University	Phase 4

See all XELJANZ XR clinical trials

Recent Litigation for XELJANZ XR

Identify potential future generic entrants

District Court Litigation

Case Name	Date
PFIZER INC. v. ZYDUS PHARMACEUTICALS (USA) INC.	2020-02-28
Pfizer Inc. v. Ajanta Pharma Ltd.	2019-03-15
Pfizer Inc. v. Teva Pharmaceuticals USA, Inc.	2018-12-07

See all XELJANZ XR litigation

Pharmacology for XELJANZ XR

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Synonyms for XELJANZ XR

(3R,4R)-4-Methyl-3-(methyl-7H-pyrro lo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidinepro panenitrile citrate

(3R,4R)-4-Methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-?-oxo-1-piperidinepropanenitrile citrate

(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidine propanenitrile 2-hydroxy-1,2,3-propanetricarboxylate

(3R,4R)-4-Methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-ss-oxo-1-piperidinepropanenitrile citrate salt

1-Piperidinepropanenitrile, 4-methyl-3-(methyl-7H-pyrrolo(2,3-d)pyrimidin-4-ylamino)- beta-oxo-, (3R,4R)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

1-PIPERIDINEPROPANENITRILE,4-METHYL-3-(METHYL-7H-PYRROLO[2,3-D]PYRIMIDIN-4-YLAMINO)-BETA-OXO-,(3R,4R)-,2-HYDROXY-1,2,3-PROPANETRICARBOXYLATE(1:1)

2-hydroxypropane-1,2,3-tricarboxylic acid;3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile

3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile mono citrate salt

3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate salt

3-{(3R,4R)-4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Mono Citrate Salt

3-{(3R,4R)-4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl}-amino]-piperidin-1-yl)-3-oxo-propionitrile citrate salt

3-{(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl}-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

540737-29-9

AB0033779

AC-25004

AKOS022178222

AOB87768

API0017273

AS-19392

AX8223835

C16H20N6O.C6H8O7

C22H28N6O8

CEP-18770(Delanzomib)

CHEBI:71197

CHEMBL2103743

CP 690550 citrate

CP 690550-10

CP-690,550-10

CP-690550 - Tofacitinib citrate

CP-690550 citrate

CP-690550 Citrate (Tofacitinib Citrate)

CP-690550-10

CS-0928

D09783

DTXSID80202404

EX-A204

HY-40354A

MLS006010058

O1FF4DIV0D

PB31590

Q-3287

Q27139435

s5001

SC-12808

SCHEMBL1374185

SMR004701220

ST24050181

SYIKUFDOYJFGBQ-YLAFAASESA-N

Tasocitinib citrate

Tofacitinib (citrate)

Tofacitinib (CP-690550) Citrate

Tofacitinib citrate

Tofacitinib citrate (CP-690550 citrate)

Tofacitinib citrate (JAN/USAN)

Tofacitinib citrate [USAN]

Tofacitinib citrate, >=98% (HPLC)

Tofacitinib citrate(CP690550)

Tofacitinib monocitrate

UNII-O1FF4DIV0D

X7518

Xeljanz

Xeljanz (TN)

Paragraph IV (Patent) Challenges for XELJANZ XR

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

US Patents and Regulatory Information for 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 Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	Yes				Y
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	Yes
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	Yes				Y
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	No				Y
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	Yes
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	No				Y

International Patents for XELJANZ XR

Country	Patent Number	Estimated Expiration
Canada	2472085
Japan	H09506116
Cyprus	1108850
Canada	2905604
Japan	4381137
Argentina	037635

Supplementary Protection Certificates for XELJANZ XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733067	10299044	Germany		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
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	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
1666481	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	CA 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	CA 2003 00002	Denmark