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Last Updated: August 11, 2022

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® Generic Entry Outlook for Xeljanz

Xeljanz was eligible for patent challenges on November 6, 2016.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tofacitinib citrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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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
Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPhase 4
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4

See all XELJANZ clinical trials

Pharmacology 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XELJANZ

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 See Plans and Pricing See Plans and Pricing
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 See Plans and Pricing See Plans and Pricing
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 See Plans and Pricing See Plans and Pricing
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 See Plans and Pricing See Plans and Pricing
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 See Plans and Pricing See Plans and Pricing
>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
Australia 1295001 See Plans and Pricing
Denmark 1666481 See Plans and Pricing
African Intellectual Property Organization (OAPI) 12118 PyrroloÄ2,3-dÜpyrimidine compounds. See Plans and Pricing
Iceland 6383 See Plans and Pricing
New Zealand 530380 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 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XELJANZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 122017000062 Germany See Plans and Pricing PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 2017/036 Ireland See Plans and Pricing 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
1666481 2017C/032 Belgium See Plans and Pricing PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481 615 Finland See Plans and Pricing
1666481 C201730033 Spain See Plans and Pricing PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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.