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Last Updated: March 19, 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 SLAYBACK PHARMA LLC on September 25th, 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
University of Alabama at BirminghamPhase 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: ⤷  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

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 ⤷  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 208246-002 Dec 12, 2019 RX Yes Yes ⤷  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 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 208246-001 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 208246-001 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
>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

Cyprus

Patent: 24007
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

Patent: 49055
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

Patent: 21000550
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

Patent: 220151016
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
Hungary S1900008 ⤷  Try a Trial
Spain 2369226 ⤷  Try a Trial
Australia 706700 ⤷  Try a Trial
Georgia, Republic of P20063784 Optical Resolution of (1-Benzyl-4- Methylpiperidin-3-Yl) -Methylamine Enantiomers and Use Thereof for Preparation of Pyrrolo 2,3-Pyrimidine Derivatives as Protein Kinases Inhibitors ⤷  Try a Trial
Israel 112585 N-terminally chemically modified G-CSF and analogs process for their preparation and pharmaceutical compositions containing them ⤷  Try a Trial
Argentina 037635 FORMAS CRISTALINAS Y AMORFAS DE LA SAL MONOCITRATO DE 3-[4-METIL-3-[METIL-(7H-PIRROLO[2,3-D] PIRIMIDIN-4-IL)-AMINO]- PIPERIDIN-1-IL)-3-OXO-PROPIONITRILO, COMPOSICIONES FARMACEUTICAS QUE LO CONTIENEN, USO EN LA MANUFACTURA DE MEDICAMENTOS Y PROCEDIMIENTO PARA OBTENER UNA FORMA CRISTALIZADA ⤷  Try a Trial
Iceland 3023 ⤷  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 615 Finland ⤷  Try a Trial
0733067 300106 Netherlands ⤷  Try a Trial PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
0733067 10299044 Germany ⤷  Try a Trial PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
1666481 C201730033 Spain ⤷  Try a Trial PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
0733067 02C0048 France ⤷  Try a Trial PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
1666481 300887 Netherlands ⤷  Try a 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 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
>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.