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Last Updated: October 26, 2021

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Tofacitinib citrate - Generic Drug Details

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What are the generic sources for tofacitinib citrate and what is the scope of freedom to operate?

Tofacitinib citrate is the generic ingredient in four branded drugs marketed by Pfizer, Zydus Pharms, Ajanta Pharma Ltd, and Pf Prism Cv, and is included in five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tofacitinib citrate has one hundred and fifty-two patent family members in fifty-five countries.

There are twelve drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for tofacitinib citrate

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

SponsorPhase
TWi Biotechnology, Inc.Phase 1
Hanlim Pharm. Co., Ltd.Phase 1
PfizerPhase 1

See all tofacitinib citrate clinical trials

Generic filers with tentative approvals for TOFACITINIB CITRATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever TrialEQ 10MG BASE TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tofacitinib citrate
Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE
Tradename Dosage Ingredient NDA Submissiondate
XELJANZ TABLET;ORAL tofacitinib citrate 203214 2016-11-07
XELJANZ XR TABLET, EXTENDED RELEASE;ORAL tofacitinib citrate 208246 2016-11-07

US Patents and Regulatory Information for tofacitinib citrate

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 tofacitinib citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tofacitinib citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 17C1031 France ⤷  Free Forever 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 2017/036 Ireland ⤷  Free Forever Trial 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 300887 Netherlands ⤷  Free Forever 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 ⤷  Free Forever Trial PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 C201730033 Spain ⤷  Free Forever 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:

Medtronic
Dow
Baxter
Colorcon
Moodys
McKinsey

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