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.
Summary for tofacitinib citrate
International Patents: | 154 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 4 |
NDAs: | 5 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 9 |
Patent Applications: | 370 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tofacitinib citrate |
DailyMed Link: | tofacitinib citrate at DailyMed |
Recent Clinical Trials for tofacitinib citrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
China-Japan Friendship Hospital | Phase 4 |
CAGE Bio Inc. | Phase 1/Phase 2 |
Pi Research Consultancy Center, Bangladesh | Early Phase 1 |
Generic filers with tentative approvals for TOFACITINIB CITRATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 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
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus 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
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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