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Last Updated: January 24, 2020

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XELJANZ Drug Profile

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When do Xeljanz patents expire, and when can generic versions of Xeljanz launch?

Xeljanz is a drug marketed by Pf Prism Cv and Pfizer Inc and is included in two NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ninety-three patent family members in fifty-nine 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.

US ANDA Litigation and Generic Entry Outlook for Xeljanz

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

There have been twelve 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.

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
Hanlim Pharm. Co., Ltd.Phase 1
Charite University, Berlin, GermanyPhase 4
Stanford UniversityPhase 1

See all XELJANZ clinical trials

Recent Litigation for XELJANZ

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Ajanta Pharma Ltd.2019-03-15
Pfizer Inc. v. Teva Pharmaceuticals USA, Inc.2018-12-07
Pfizer Inc. v. Sun Pharmaceutical Industries Limited2018-10-03

See all XELJANZ litigation

Pharmacology for XELJANZ
Paragraph IV (Patent) Challenges for XELJANZ
Tradename Dosage Ingredient NDA Submissiondate
XELJANZ TABLET;ORAL tofacitinib citrate 203214 2016-11-07

US Patents and Regulatory Information for XELJANZ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for XELJANZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 PA2017025,C1666481 Lithuania   Start Trial PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 CA 2017 00035 Denmark   Start 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 C201730033 Spain   Start Trial 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:

Colorcon
McKinsey
Express Scripts
AstraZeneca
Mallinckrodt
Dow

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