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Last Updated: November 2, 2024

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 four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and twenty-three 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 HIKMA on September 25th, 2023.

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Drug patent expirations by year for XELJANZ XR
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Recent Clinical Trials for XELJANZ XR

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

SponsorPhase
TakedaPhase 4
Children's Hospital Los AngelesPhase 2
Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPhase 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 seven US patents and one FDA Regulatory Exclusivity.

Patents protecting XELJANZ XR

Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Sign Up
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Tofacitinib oral sustained release dosage forms
Patent Number: ⤷  Sign Up
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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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
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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
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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

Tofacitinib oral sustained release dosage forms
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Pyrrolo[2,3-D]pyrimidine compounds
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Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 208246-001 Feb 23, 2016 ⤷  Sign Up ⤷  Sign Up
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 ⤷  Sign Up ⤷  Sign Up
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Sign Up ⤷  Sign Up
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Sign Up ⤷  Sign Up
>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
Patent: FORMA DE DOSIS ORALES DE LIBERACIÓN SOSTENIDA DE TOFACITINIB
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 14233850
Patent: Tofacitinib oral sustained release dosage forms
Estimated Expiration: ⤷  Sign Up

Patent: 17203334
Patent: Tofacitinib oral sustained release dosage forms
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015020453
Patent: formas de dosagem de liberação prolongada orais de tofacitinibe
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 05604
Patent: FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB A LIBERATION PROLONGEE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 37328
Patent: FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB A LIBERATION PROLONGEE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 5101952
Patent: Tofacitinib oral sustained release dosage forms
Estimated Expiration: ⤷  Sign Up

Patent: 1419817
Patent: 托法替尼口服持续释放剂型 (Tofacitinib oral sustained release dosage form)
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 24007
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 68155
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 68155
Patent: FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB À LIBÉRATION PROLONGÉE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 54400
Patent: FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB À LIBÉRATION PROLONGÉE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 49055
Patent: FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB À LIBÉRATION PROLONGÉE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 17297
Patent: 托法替尼口服持續釋放劑型 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 53911
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1400
Patent: תכשירים למתן אורלי של טופאסיטיניב (Tofacitinib oral sustained release dosage forms)
Estimated Expiration: ⤷  Sign Up

Patent: 7967
Patent: תכשירים למתן אורלי של טופאסיטיניב (Tofacitinib oral sustained release dosage forms)
Estimated Expiration: ⤷  Sign Up

Patent: 3032
Patent: תכשירים למתן אורלי של טופאסיטיניב (Tofacitinib oral sustained release dosage forms)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 41823
Estimated Expiration: ⤷  Sign Up

Patent: 14188
Estimated Expiration: ⤷  Sign Up

Patent: 14181234
Patent: TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS
Estimated Expiration: ⤷  Sign Up

Patent: 16199602
Patent: トファシチニブの経口持続放出剤形 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 18100300
Patent: トファシチニブの経口持続放出剤形 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
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Mexico

Patent: 15013279
Patent: FORMA DE DOSIS ORALES DE LIBERACION SOSTENIDA DE TOFACITINIB. (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS.)
Estimated Expiration: ⤷  Sign Up

Patent: 21000550
Patent: FORMA DE DOSIS ORALES DE LIBERACION SOSTENIDA DE TOFACITINIB. (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0792
Patent: Tofacitinib oral sustained release dosage forms
Estimated Expiration: ⤷  Sign Up

Patent: 1227
Patent: Tofacitinib oral sustained release dosage forms
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 68155
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 68155
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 74345
Patent: ОРАЛЬНЫЕ ДОЗИРОВАННЫЕ ФОРМЫ ТОФАЦИТИНИБА С НЕПРЕРЫВНЫМ ВЫСВОБОЖДЕНИЕМ (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 15139505
Patent: ОРАЛЬНЫЕ ДОЗИРОВАННЫЕ ФОРМЫ ТОФАЦИТИНИБА С НЕПРЕРЫВНЫМ ВЫСВОБОЖДЕНИЕМ
Estimated Expiration: ⤷  Sign Up

Patent: 18129861
Patent: ОРАЛЬНЫЕ ДОЗИРОВАННЫЕ ФОРМЫ ТОФАЦИТИНИБА С НЕПРЕРЫВНЫМ ВЫСВОБОЖДЕНИЕМ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201810985X
Patent: TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS
Estimated Expiration: ⤷  Sign Up

Patent: 201506103U
Patent: TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 68155
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1505468
Patent: TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS
Estimated Expiration: ⤷  Sign Up

Patent: 1905100
Patent: TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2151842
Estimated Expiration: ⤷  Sign Up

Patent: 2213616
Estimated Expiration: ⤷  Sign Up

Patent: 150131238
Patent: 토파시티닙 경구용 지속 방출 투여 형태 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 170121332
Patent: 토파시티닙 경구용 지속 방출 투여 형태 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 200103892
Patent: 토파시티닙 경구용 지속 방출 투여 형태 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Patent: 210014763
Patent: 토파시티닙 경구용 지속 방출 투여 형태 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
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Patent: 220151016
Patent: 토파시티닙 경구용 지속 방출 투여 형태 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 65134
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 19516
Estimated Expiration: ⤷  Sign Up

Patent: 1436823
Patent: Tofacitinib oral sustained release dosage forms
Estimated Expiration: ⤷  Sign Up

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
New Zealand 528905 Pyrrolo[2,3-d]pyrimidine compounds ⤷  Sign Up
Japan 4381137 ⤷  Sign Up
Slovenia 1235830 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 0142246 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XELJANZ XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0733067 6/2003 Austria ⤷  Sign Up PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
1666481 122017000062 Germany ⤷  Sign Up PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 17C1031 France ⤷  Sign Up PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0733067 10299044 Germany ⤷  Sign Up PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.