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Last Updated: October 1, 2023

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.

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Drug patent expirations by year for XELJANZ
Drug Prices for XELJANZ

See drug prices for XELJANZ

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 PennsylvaniaPhase 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 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

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 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 208246-002 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
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 AB RX Yes No ⤷  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 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

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

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Johnson and Johnson
Mallinckrodt
Express Scripts
Boehringer Ingelheim

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