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Last Updated: August 8, 2020

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XELJANZ XR Drug Profile

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When do Xeljanz Xr patents expire, and what generic alternatives are available?

Xeljanz Xr is a drug marketed by Pfizer Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-one patent family members in sixty countries.

The generic ingredient in XELJANZ XR 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 Xr

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

There have been fourteen 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 XR
Drug Prices for XELJANZ XR

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Recent Clinical Trials for XELJANZ XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
TWi Biotechnology, Inc.Phase 1
Ospedale di Circolo e Fondazione Macchi, VaresePhase 2
ASST Papa Giovanni XXIII, BergamoPhase 2

See all XELJANZ XR clinical trials

Pharmacology for XELJANZ XR
Paragraph IV (Patent) Challenges for XELJANZ XR
Tradename Dosage Ingredient NDA Submissiondate
XELJANZ XR TABLET, EXTENDED RELEASE;ORAL tofacitinib citrate 208246 2016-11-07

US Patents and Regulatory Information for XELJANZ XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes   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 Y   Start Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 RX Yes No   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 Y   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 XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0733067 5/2003 Austria   Start Trial PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
0733067 300106 Netherlands   Start Trial PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
0733067 SZ 5/2003 Austria   Start Trial PRODUCT NAME: PEGFILGRASTIM
1235830 C01235830/01 Switzerland   Start 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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