Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
Covington
Healthtrust
Citi
Accenture
QuintilesIMS
Merck
Federal Trade Commission

Generated: August 15, 2018

DrugPatentWatch Database Preview

XELJANZ XR Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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.

Drug patent expirations by year for XELJANZ XR
Generic Entry Opportunity Date for XELJANZ XR
Generic Entry Date for XELJANZ XR*:
Constraining patent/regulatory exclusivity:
NDA:
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
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Paragraph IV (Patent) Challenges for XELJANZ XR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 11 mg ➤ Subscribe ➤ Try a Free Trial

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 ➤ Try a Free Trial
7,432,370 Chiral salt resolution ➤ Try a Free Trial
7,842,699 Pyrrolo[2,3-D]pyrimidine compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for XELJANZ XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
Citi
Colorcon
Deloitte
AstraZeneca
Cerilliant
Mallinckrodt
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.