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Last Updated: March 28, 2024

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 Slayback Pharma Llc, Pfizer, Zydus Pharms, Ajanta Pharma Ltd, Micro Labs, and Pf Prism Cv, and is included in eight 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 twenty-three 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 are three tentative approvals 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
⤷  Try a Trial⤷  Try a TrialEQ 5MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 10MG BASE TABLET;ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET;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
Drug ClassJanus Kinase Inhibitor
Mechanism of ActionJanus Kinase Inhibitors
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
Zydus Pharms TOFACITINIB CITRATE tofacitinib citrate TABLET;ORAL 209829-001 Mar 13, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-002 May 30, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zydus Pharms TOFACITINIB tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 214264-001 Aug 19, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 203214-002 May 30, 2018 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-002 Dec 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer XELJANZ tofacitinib citrate SOLUTION;ORAL 213082-001 Sep 25, 2020 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for tofacitinib citrate

Country Patent Number Title Estimated Expiration
Iceland 6383 ⤷  Try a Trial
Japan 2014181234 TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS ⤷  Try a Trial
Denmark 1382339 ⤷  Try a Trial
Hungary 229671 PYRROLO[2,3-D]PIRIMIDINE COMPOUNDS ⤷  Try a Trial
New Zealand 528905 Pyrrolo[2,3-d]pyrimidine compounds ⤷  Try a Trial
Egypt 24399 Pyrrolo[2,3-D]pyrimidine compounds ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tofacitinib citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1666481 LUC00031 Luxembourg ⤷  Try a Trial 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 CA 2017 00035 Denmark ⤷  Try a 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 300887 Netherlands ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481 37/2017 Austria ⤷  Try a Trial PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324
1666481 2017C/032 Belgium ⤷  Try a Trial PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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