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Last Updated: January 27, 2023

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 five 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-four 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
China-Japan Friendship HospitalPhase 4
CAGE Bio Inc.Phase 1/Phase 2
Pi Research Consultancy Center, BangladeshEarly Phase 1

See all tofacitinib citrate clinical trials

Generic filers with tentative approvals for TOFACITINIB CITRATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 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 Strength NDA ANDAs Submitted Submissiondate
XELJANZ Oral Solution tofacitinib citrate 1 mg/mL 213082 1 2021-11-12
XELJANZ XR Extended-release Tablets tofacitinib citrate 22 mg 208246 1 2020-12-28
XELJANZ Tablets tofacitinib citrate 10 mg 203214 1 2019-07-24
XELJANZ Tablets tofacitinib citrate 5 mg 203214 3 2016-11-07
XELJANZ XR Extended-release Tablets tofacitinib citrate 11 mg 208246 1 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 203214-002 May 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 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 See Plans and Pricing
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms TOFACITINIB tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 214264-002 Aug 19, 2021 DISCN No No See Plans and Pricing See Plans and Pricing 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
>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
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 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
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 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 203214-001 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 tofacitinib citrate

Country Patent Number Title Estimated Expiration
Japan 2018100300 トファシチニブの経口持続放出剤形 (TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS) See Plans and Pricing
Portugal 1235830 See Plans and Pricing
Egypt 24399 Pyrrolo[2,3-D]pyrimidine compounds See Plans and Pricing
South Africa 200404270 NOVEL CRYSTALLINE COMPOUND See Plans and Pricing
Germany 60239146 See Plans and Pricing
Portugal 1382339 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tofacitinib citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 17C1031 France See Plans and Pricing 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 See Plans and Pricing 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 300887 Netherlands See Plans and Pricing 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 132017000095300 Italy See Plans and Pricing PRODUCT NAME: TOFACITINIB, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRENDENTE IL SALE CITRATO(XELJANZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1178/001-004, 20170324
1666481 PA2017025 Lithuania See Plans and Pricing PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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