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Last Updated: April 9, 2020

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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 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 eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tofacitinib citrate has two hundred and twenty-one patent family members in sixty countries.

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

Recent Clinical Trials for tofacitinib citrate

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

SponsorPhase
Hanlim Pharm. Co., Ltd.Phase 1
PfizerPhase 1
Johns Hopkins UniversityPhase 1

See all tofacitinib citrate clinical trials

Recent Litigation for tofacitinib citrate

Identify potential future generic entrants

District Court Litigation
Case NameDate
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 tofacitinib citrate litigation

Pharmacology for tofacitinib citrate
Synonyms for tofacitinib citrate
(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 (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)
Xeljanz Xr
Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE
Tradename Dosage Ingredient NDA Submissiondate
XELJANZ XR TABLET, EXTENDED RELEASE;ORAL tofacitinib citrate 208246 2016-11-07
XELJANZ TABLET;ORAL tofacitinib citrate 203214 2016-11-07

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 No   Start Trial   Start Trial Y   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for tofacitinib citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 PA2017025,C1666481 Lithuania   Start Trial PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 122017000062 Germany   Start Trial PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 LUC00031 Luxembourg   Start Trial PRODUCT NAME: TOFACITINIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE CITRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481 1790038-2 Sweden   Start Trial 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 2017C/032 Belgium   Start Trial PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481 300887 Netherlands   Start Trial PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1666481 CA 2017 00035 Denmark   Start Trial PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Harvard Business School
Johnson and Johnson
Moodys
Dow

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