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XELJANZ XR Drug Profile

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Which patents cover Xeljanz Xr, and what generic alternatives are available?

Xeljanz Xr is a drug marketed by Pfizer Inc and is included in one NDA. There are seven 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^th, 2016.

There have been twelve 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.

Summary for XELJANZ XR

International Patents:	221
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	64
Clinical Trials:	13
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
Hanlim Pharm. Co., Ltd.	Phase 1
Charite University, Berlin, Germany	Phase 4
Stanford University	Phase 1

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. Ajanta Pharma Ltd.	2019-03-15
Pfizer Inc. v. Teva Pharmaceuticals USA, Inc.	2018-12-07
Pfizer Inc. v. Sun Pharmaceutical Industries Limited	2018-10-03

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-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

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

BC600313

C22H28N6O8

CEP-18770(Delanzomib)

CHEBI:71197

CHEMBL2103743

citro; tofacitinib

CP 690550 citrate

CP-690,550-10

CP-690550 - Tofacitinib citrate

CP-690550 citrate

CP-690550-10

CS-0928

D09783

DTXSID80202404

EX-A204

HY-40354A

MLS006010058

MolPort-023-293-518

O1FF4DIV0D

PB31590

Q-3287

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)

UNII-O1FF4DIV0D

X7518

Xeljanz

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
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				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	208246-001	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				Y

International Patents for XELJANZ XR

Country	Patent Number	Estimated Expiration
Israel	241400
Tunisia	SN03128
Luxembourg	C00031
New Zealand	518884
Yugoslavia	92303
Turkey	200400105
New Zealand	530380

Supplementary Protection Certificates for XELJANZ XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	1790038-2	Sweden		PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REG. NO/DATE: EU/1/17/1178 20170324
1666481	PA2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1235830	C01235830/01	Switzerland		PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013