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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Summary for XELJANZ XR
| International Patents: | 123 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 30 |
| Patent Applications: | 106 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XELJANZ XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ XR |
| DailyMed Link: | XELJANZ XR at DailyMed |
Recent Clinical Trials for XELJANZ XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 4 |
| Children's Hospital Los Angeles | Phase 2 |
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Phase 4 |
Pharmacology for XELJANZ XR
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus 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
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Tofacitinib oral sustained release dosage forms
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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
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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
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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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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 | ||||
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | 208246-001 | 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 |
| >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)
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Argentina | 026534 | COMPUESTOS DE PIRROLO[2,3-D]PIRIMIDINA, COMPOSICION FARMACEUTICA QUE LOS CONTIENE, SU USO COMO MEDICAMENTO, SU USO PARA LA MANUFACTURA DE UN MEDICAMENTO Y COMBINACION DE LOS MISMOS CON AGENTAS MODULADORES DEL SISTEMA INMUNE O ANTIINFLAMATORIO | ⤷ Sign Up |
| Singapore | 11201506103U | TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS | ⤷ Sign Up |
| Norway | 20093135 | ⤷ Sign Up | |
| South Korea | 100868814 | ⤷ Sign Up | |
| Australia | 2014233850 | Tofacitinib oral sustained release dosage forms | ⤷ 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 | SPC033/2002 | Ireland | ⤷ Sign Up | SPC033/2002: 20050111, EXPIRES: 20170821 |
| 1666481 | 300887 | Netherlands | ⤷ Sign Up | 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 | 2017C/032 | Belgium | ⤷ Sign Up | PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
| 0733067 | C300106 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PEGFILGRASTIM; NAT. REGISTRATION NO/DATE: EU/1/02/228/001 20020822; FIRST REGISTRATION: EU/1/02/228/001 20020822 |
| 0733067 | SPC/GB03/006 | United Kingdom | ⤷ Sign Up | 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 |
| >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.
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