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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Moodys
Daiichi Sankyo
Colorcon
Healthtrust
Citi
Harvard Business School
US Army
Federal Trade Commission

Generated: July 18, 2018

DrugPatentWatch Database Preview

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 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 five patent family members in fifty-eight countries.

There are eleven drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound.
Pharmacology for tofacitinib citrate
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 203214-002 May 30, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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
6,627,754 Pyrrolo[2,3-d]pyrimidine compounds ➤ Try a Free Trial
7,601,727 Pyrrolo[2,3-d]pyrimidine compounds ➤ Try a Free Trial
7,432,370 Chiral salt resolution ➤ Try a Free Trial
7,803,805 Cristalline 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for tofacitinib citrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00035 Denmark ➤ Try a Free 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
0887 Netherlands ➤ Try a Free 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
2017025 Lithuania ➤ Try a Free Trial PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
2017000062 Germany ➤ Try a Free Trial PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
McKesson
McKinsey
Deloitte
Federal Trade Commission
Boehringer Ingelheim
Dow
Argus Health

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