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Tofacitinib citrate - Generic Drug Details

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What are the generic sources for tofacitinib citrate and what is the scope of tofacitinib citrate freedom to operate?

Tofacitinib citrate is the generic ingredient in two branded drugs marketed by Pfizer Inc and Pf Prism Cv, and is included in two NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tofacitinib citrate has one hundred and eighty-five patent family members in fifty-seven countries.

There are eleven drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound.

Summary for tofacitinib citrate

International Patents:	185
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	11
Suppliers / Packagers:	2
Bulk Api Vendors:	45
Clinical Trials:	578
Patent Applications:	23
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	tofacitinib citrate at DailyMed

Pharmacology for tofacitinib citrate

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Synonyms for tofacitinib 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)-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 (CP-690550 citrate)

Tofacitinib citrate (JAN/USAN)

Tofacitinib citrate [USAN]

Tofacitinib citrate, >=98% (HPLC)

Tofacitinib citrate(CP690550)

TOFACITINIB, CITRATE SALT

UNII-O1FF4DIV0D

X7518

Xeljanz Xr

US Patents and Regulatory Information for tofacitinib citrate

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

Non-Orange Book US Patents for tofacitinib citrate

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
7,842,699	Pyrrolo[2,3-D]pyrimidine compounds
6,627,754	Pyrrolo[2,3-d]pyrimidine compounds
7,432,370	Chiral salt resolution
7,601,727	Pyrrolo[2,3-d]pyrimidine compounds

International Patents for tofacitinib citrate

Country	Document Number	Estimated Expiration
Russian Federation	2315052
Canada	2393640
Norway	323378
Australia	2002304401

Supplementary Protection Certificates for tofacitinib citrate

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
1235830/01	Switzerland		PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
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
2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322