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Last Updated: March 28, 2024

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 four patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-five patent family members in fifty-two 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 SLAYBACK PHARMA LLC on September 25th, 2023.

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Drug patent expirations by year for XELJANZ
Drug Prices for XELJANZ

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Recent Clinical Trials for XELJANZ

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 NebraskaPhase 4

See all XELJANZ clinical trials

Pharmacology for XELJANZ
Drug ClassJanus Kinase Inhibitor
Mechanism of ActionJanus Kinase Inhibitors
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 one US patents and one FDA Regulatory Exclusivity.

Patents protecting XELJANZ

Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting XELJANZ

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 tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 AA 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 Y ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 RX Yes Yes ⤷  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 ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 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
>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

International Patents for XELJANZ

See the table below for patents covering XELJANZ around the world.

Country Patent Number Title Estimated Expiration
China 1596257 ⤷  Try a Trial
South Korea 20060014459 ⤷  Try a Trial
Ecuador SP003819 COMPUESTOS DE PIRROLO (2,3-d) PIRIMIDINA ⤷  Try a Trial
European Patent Office 1609781 Méthode pour la résolution optique de (1-benzyl-4-méthylpiperidin-3-yl)-méthylamine (Optical resolution of (1-benzyl-4-methylpiperidin-3-yl)-methylamine) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 0142246 ⤷  Try a Trial
South Korea 100868814 ⤷  Try a Trial
Mexico PA03011062 RESOLUCION OPTICA DE (1-BENCIL-4-METILPIPERIDIN-3-IL)-METILAMINA Y EL USO DE LA MISMA PARA LA PREPARACION DE DERIVADOS DE PIRROLO 2,3-PIRIMIDINA COMO INHIBIDORES DE PROTEINA QUINASAS. (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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XELJANZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CA 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
1666481 122017000062 Germany ⤷  Try a Trial PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
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 2017C/032 Belgium ⤷  Try a Trial PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481 PA2017025 Lithuania ⤷  Try a Trial PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 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.