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Last Updated: August 15, 2022

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-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® Generic Entry Outlook for Xeljanz Xr

Xeljanz Xr was eligible for patent challenges on November 6, 2016.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tofacitinib citrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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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
Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPhase 4
University of NebraskaPhase 4
NovartisPhase 4

See all XELJANZ XR clinical trials

Pharmacology for XELJANZ XR
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tofacitinib oral sustained release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tofacitinib oral sustained release dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 14233850
Estimated Expiration: See Plans and Pricing

Patent: 17203334
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015020453
Estimated Expiration: See Plans and Pricing

Canada

Patent: 05604
Estimated Expiration: See Plans and Pricing

Patent: 37328
Estimated Expiration: See Plans and Pricing

China

Patent: 5101952
Estimated Expiration: See Plans and Pricing

Patent: 1419817
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68155
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68155
Estimated Expiration: See Plans and Pricing

Patent: 54400
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 17297
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 53911
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1400
Estimated Expiration: See Plans and Pricing

Patent: 7967
Estimated Expiration: See Plans and Pricing

Patent: 3032
Estimated Expiration: See Plans and Pricing

Japan

Patent: 41823
Estimated Expiration: See Plans and Pricing

Patent: 14188
Estimated Expiration: See Plans and Pricing

Patent: 14181234
Estimated Expiration: See Plans and Pricing

Patent: 16199602
Estimated Expiration: See Plans and Pricing

Patent: 18100300
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15013279
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0792
Estimated Expiration: See Plans and Pricing

Patent: 1227
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68155
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68155
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 74345
Estimated Expiration: See Plans and Pricing

Patent: 15139505
Estimated Expiration: See Plans and Pricing

Patent: 18129861
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201810985X
Estimated Expiration: See Plans and Pricing

Patent: 201506103U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68155
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1505468
Estimated Expiration: See Plans and Pricing

Patent: 1905100
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2151842
Estimated Expiration: See Plans and Pricing

Patent: 2213616
Estimated Expiration: See Plans and Pricing

Patent: 150131238
Estimated Expiration: See Plans and Pricing

Patent: 170121332
Estimated Expiration: See Plans and Pricing

Patent: 200103892
Estimated Expiration: See Plans and Pricing

Patent: 210014763
Estimated Expiration: See Plans and Pricing

Spain

Patent: 65134
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 19516
Estimated Expiration: See Plans and Pricing

Patent: 1436823
Estimated Expiration: See Plans and Pricing

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
Tunisia SN03128 RESOLUTION OPTIQUE DE LA (1-BENZYL-4-METHYLPIPERIDINE-3-YL) METHYLAMINE ET SON UTILISATION POUR LA PREPARATION DE DERIVES DE PYRROLO 2,3-PYRIMIDINE SERVANT D'INHIBITEURS DE PROTEINES KINASES See Plans and Pricing
Austria 257157 See Plans and Pricing
Taiwan 200300690 See Plans and Pricing
Canada 2178752 COMPOSITIONS DE PROTEINES AYANT SUBI UNE MODIFICATION CHIMIQUE A L'EXTREMITE N-TERMINALE ET PROCEDES (N-TERMINALLY CHEMICALLY MODIFIED PROTEIN COMPOSITIONS AND METHODS) See Plans and Pricing
Czech Republic 20021846 See Plans and Pricing
Brazil 0209246 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 CR 2017 00035 Denmark See Plans and Pricing PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
0733067 5/2003 Austria See Plans and Pricing PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
0733067 SPC/GB03/006 United Kingdom See Plans and Pricing PRODUCT NAME: PEGFILGRASTIM, AN N-TERMINALLY MONOPEGYLATED G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR); REGISTERED: UK EU/1/02/228/001 20020826; UK EU/1/02/227/001 20020826
1666481 C201730033 Spain See Plans and Pricing 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 SPC033/2002 Ireland See Plans and Pricing SPC033/2002: 20050111, EXPIRES: 20170821
>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.