XELJANZ Drug Patent Profile
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Which patents cover Xeljanz, and when can generic versions of Xeljanz launch?
Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. There are five patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and nine patent family members in fifty-four countries.
The generic ingredient in XELJANZ 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
A generic version of XELJANZ was approved as tofacitinib citrate by ZYDUS PHARMS on March 13th, 2023.
Summary for XELJANZ
International Patents: | 109 |
US Patents: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 29 |
Patent Applications: | 137 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for XELJANZ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ |
What excipients (inactive ingredients) are in XELJANZ? | XELJANZ excipients list |
DailyMed Link: | XELJANZ at DailyMed |


Recent Clinical Trials for XELJANZ
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 Pennsylvania | Phase 4 |
Pharmacology for XELJANZ
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for XELJANZ
Paragraph IV (Patent) Challenges for XELJANZ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XELJANZ | Oral Solution | tofacitinib citrate | 1 mg/mL | 213082 | 1 | 2021-11-12 |
XELJANZ | Tablets | tofacitinib citrate | 10 mg | 203214 | 1 | 2019-07-24 |
XELJANZ | Tablets | tofacitinib citrate | 5 mg | 203214 | 3 | 2016-11-07 |
US Patents and Regulatory Information for XELJANZ
XELJANZ is protected by two US patents and three FDA Regulatory Exclusivities.
Patents protecting XELJANZ
Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate
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
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
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
Expired US Patents for XELJANZ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | XELJANZ | tofacitinib citrate | SOLUTION;ORAL | 213082-001 | Sep 25, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XELJANZ
See the table below for patents covering XELJANZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | S1900008 | ⤷ Try a Trial | |
Poland | 409305 | ⤷ 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 |
Norway | 20093135 | ⤷ Try a Trial | |
Netherlands | 300887 | ⤷ Try a Trial | |
Japan | 4381137 | ⤷ Try a Trial | |
Bulgaria | 108389 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 2017C/032 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
1666481 | PA2017025,C1666481 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
1666481 | 17C1031 | France | ⤷ Try a Trial | 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 |
1666481 | LUC00031 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE CITRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
1666481 | 1790038-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REG. NO/DATE: EU/1/17/1178 20170324 |
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 |