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Last Updated: April 4, 2020

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XELJANZ Drug Profile


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Which patents cover Xeljanz, and when can generic versions of Xeljanz launch?

Xeljanz is a drug marketed by Pf Prism Cv and Pfizer Inc and is included in two NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ninety-three patent family members in fifty-nine countries.

The generic ingredient in XELJANZ 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

Xeljanz 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

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Drug patent expirations by year for XELJANZ
Drug Prices for XELJANZ

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Recent Clinical Trials for XELJANZ

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SponsorPhase
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Phase 2
University of Colorado, DenverPhase 2
Shanghai Zhongshan HospitalPhase 4

See all XELJANZ clinical trials

Recent Litigation for XELJANZ

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 XELJANZ litigation

Pharmacology for XELJANZ
Synonyms for XELJANZ
(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 (TN)
Xeljanz Xr
Paragraph IV (Patent) Challenges for XELJANZ
Tradename Dosage Ingredient NDA Submissiondate
XELJANZ TABLET;ORAL tofacitinib citrate 203214 2016-11-07

US Patents and Regulatory Information for XELJANZ

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 208246-002 Dec 12, 2019 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   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   Start Trial   Start Trial   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 XELJANZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 PA2017025 Lithuania   Start Trial PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 C 2017 029 Romania   Start Trial 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 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 2017/036 Ireland   Start Trial PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REGISTRATION NO/DATE: EU/1/17/1178/001 EU/1/17/1178/004 20170322
>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:

Dow
Harvard Business School
Johnson and Johnson
Mallinckrodt
Express Scripts
Boehringer Ingelheim

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