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Last Updated: September 27, 2023

XELJANZ XR Drug Patent Profile


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When do Xeljanz Xr patents expire, and what generic alternatives are available?

Xeljanz Xr is a drug marketed by Pfizer and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fifty-five patent family members in fifty-five countries.

The generic ingredient in XELJANZ XR 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Xeljanz Xr

A generic version of XELJANZ XR was approved as tofacitinib citrate by ZYDUS PHARMS on March 13th, 2023.

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Drug patent expirations by year for XELJANZ XR
Drug Prices for XELJANZ XR

See drug prices for XELJANZ XR

Recent Clinical Trials for XELJANZ XR

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

SponsorPhase
Children's Hospital Los AngelesPhase 2
Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPhase 4
AbbViePhase 4

See all XELJANZ XR clinical trials

Pharmacology for XELJANZ XR
Drug ClassJanus Kinase Inhibitor
Mechanism of ActionJanus Kinase Inhibitors
Paragraph IV (Patent) Challenges for XELJANZ XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XELJANZ XR Extended-release Tablets tofacitinib citrate 22 mg 208246 1 2020-12-28
XELJANZ XR Extended-release Tablets tofacitinib citrate 11 mg 208246 1 2016-11-07

US Patents and Regulatory Information for XELJANZ XR

XELJANZ XR is protected by eight US patents and one FDA Regulatory Exclusivity.

Patents protecting XELJANZ XR

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING RHEUMATOID ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 AND 87-98

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING ULCERATIVE COLITIS, BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 AND 87-98

Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting XELJANZ XR

TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for XELJANZ XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for XELJANZ XR

When does loss-of-exclusivity occur for XELJANZ XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5487
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 14233850
Estimated Expiration: ⤷  Try a Trial

Patent: 17203334
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015020453
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 05604
Estimated Expiration: ⤷  Try a Trial

Patent: 37328
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5101952
Estimated Expiration: ⤷  Try a Trial

Patent: 1419817
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 68155
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68155
Estimated Expiration: ⤷  Try a Trial

Patent: 54400
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 17297
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 53911
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1400
Estimated Expiration: ⤷  Try a Trial

Patent: 7967
Estimated Expiration: ⤷  Try a Trial

Patent: 3032
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 41823
Estimated Expiration: ⤷  Try a Trial

Patent: 14188
Estimated Expiration: ⤷  Try a Trial

Patent: 14181234
Estimated Expiration: ⤷  Try a Trial

Patent: 16199602
Estimated Expiration: ⤷  Try a Trial

Patent: 18100300
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 15013279
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0792
Estimated Expiration: ⤷  Try a Trial

Patent: 1227
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 68155
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 68155
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 74345
Estimated Expiration: ⤷  Try a Trial

Patent: 15139505
Estimated Expiration: ⤷  Try a Trial

Patent: 18129861
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201810985X
Estimated Expiration: ⤷  Try a Trial

Patent: 201506103U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 68155
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1505468
Estimated Expiration: ⤷  Try a Trial

Patent: 1905100
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2151842
Estimated Expiration: ⤷  Try a Trial

Patent: 2213616
Estimated Expiration: ⤷  Try a Trial

Patent: 150131238
Estimated Expiration: ⤷  Try a Trial

Patent: 170121332
Estimated Expiration: ⤷  Try a Trial

Patent: 200103892
Estimated Expiration: ⤷  Try a Trial

Patent: 210014763
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 65134
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 19516
Estimated Expiration: ⤷  Try a Trial

Patent: 1436823
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XELJANZ XR around the world.

Country Patent Number Title Estimated Expiration
Poland 355907 ⤷  Try a Trial
Canada 2472085 ⤷  Try a Trial
Denmark 1382339 ⤷  Try a Trial
China 1195755 ⤷  Try a Trial
South Korea 20080002931 ⤷  Try a Trial
Japan H09506116 ⤷  Try a Trial
Slovakia 288199 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XELJANZ XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 PA2017025,C1666481 Lithuania ⤷  Try a 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 ⤷  Try a 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
0733067 SPC033/2002 Ireland ⤷  Try a Trial SPC033/2002: 20050111, EXPIRES: 20170821
1666481 615 Finland ⤷  Try a Trial
1666481 2017/036 Ireland ⤷  Try a 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
0733067 5/2003 Austria ⤷  Try a Trial PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
1666481 CR 2017 00035 Denmark ⤷  Try a 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

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