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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 five patent family members in fifty-eight countries.

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

Summary for XELJANZ XR

International Patents:	205
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	51
Clinical Trials:	6
Patent Applications:	18
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

Generic Entry Opportunity Date for XELJANZ XR

NDA:

208246

Dosage:

TABLET, EXTENDED RELEASE;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.

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

(3R,4R)-4-METHYL-3-(METHYL-7H-PYRROLO[2,3-D]PYRIMIDIN-4-YLAMINO)-BETA-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)

1-PIPERIDINEPROPANENITRILE,4-METHYL-3- -BETA-OXO-, -,2-HYDROXY-1,2,3-PROPANETRICARBOXYLATE

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-OXOPROPANENITRILE 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

AK117841

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

CP-690550-10 CITRATE SALT

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

TASOCITINIB CITRATE SALT

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, CITRATE SALT

UNII-O1FF4DIV0D

X7518

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

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Paragraph IV (Patent) Challenges for XELJANZ XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	11 mg

Non-Orange Book US Patents for XELJANZ XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,627,754	Pyrrolo[2,3-d]pyrimidine compounds
7,432,370	Chiral salt resolution
7,842,699	Pyrrolo[2,3-D]pyrimidine compounds

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International Patents for XELJANZ XR

Country	Document Number	Estimated Expiration
Austria	497962
Germany	60037345
African Regional IP Organization (ARIPO)	1859

Supplementary Protection Certificates for XELJANZ XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017000062	Germany		PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322
0887	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
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