Xeljanz XR Drug Patent Profile
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Which patents cover Xeljanz Xr, and when can generic versions of Xeljanz Xr launch?
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.
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: | 29 |
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 |
---|---|
Children's Hospital Los Angeles | Phase 2 |
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Phase 4 |
University of Nebraska | Phase 4 |
Pharmacology for Xeljanz XR
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 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
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 |
---|---|---|---|
China | 111419817 | 托法替尼口服持续释放剂型 (Tofacitinib oral sustained release dosage form) | ⤷ Try a Trial |
Japan | 6041823 | ⤷ Try a Trial | |
Ukraine | 80093 | СПОСОБ ОПТИЧЕСКОГО РАЗДЕЛЕНИЯ (1-БЕНЗИЛ-4-МЕТИЛПИПЕРИДИН-3-ИЛ)МЕТИЛАМИНА И ЕГО ИСПОЛЬЗОВАНИЕ ДЛЯ ПОЛУЧЕНИЯ ПРОИЗВОДНЫХ ПИРРОЛО[2, 3-D]ПИРИМИДИНА КАК ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ;СПОСІБ ОПТИЧНОГО РОЗДІЛЕННЯ (1-БЕНЗИЛ-4-МЕТИЛПІПЕРИДИН-3-ІЛ)МЕТИЛАМІНУ І ЙОГО ВИКОРИСТАННЯ ДЛЯ ОДЕРЖАННЯ ПОХІДНИХ ПІРОЛО[2,3-D]ПІРИМІДИНУ ЯК ІНГІБІТОРІВ ПРОТЕЇНКІНАЗИ (OPTICAL RESOLUTION OF (1-BENZYL-4-METHYLPIPERIDIN-3-YL) -METHYLAMINE AND THE USE THEREOF FOR THE PREPARATION OF PYRROLO 2,3-PYRIMIDINE DERIVATIVES AS PROTEIN KINASES INHIBITORS) | ⤷ Try a Trial |
Norway | 20022738 | ⤷ Try a Trial | |
Yugoslavia | 41302 | ⤷ Try a Trial | |
European Patent Office | 3854400 | FORMES PHARMACEUTIQUES ORALES DE TOFACITINIB À LIBÉRATION PROLONGÉE (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS) | ⤷ Try a Trial |
Japan | 2005511696 | ⤷ 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 |
---|---|---|---|---|
0733067 | 6/2003 | Austria | ⤷ Try a Trial | PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822 |
1666481 | 37/2017 | Austria | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324 |
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 |
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 |
0733067 | 10299044 | Germany | ⤷ Try a Trial | PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822 |
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 |
1235830 | C01235830/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |