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 Hikma, Pfizer, Aurobindo Pharma Ltd, Zydus Pharms, Ajanta Pharma Ltd, Micro Labs, and Pf Prism Cv, and is included in nine 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.

Summary for tofacitinib citrate

International Patents:	123
US Patents:	4
Tradenames:	4
Applicants:	7
NDAs:	9
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	10
Patent Applications:	222
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
Services Institute of Medical Sciences, Pakistan	Early Phase 1

See all tofacitinib citrate clinical trials

Generic filers with tentative approvals for TOFACITINIB CITRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	EQ 5MG BASE	TABLET;ORAL
⤷ Subscribe	⤷ Subscribe	EQ 10MG BASE	TABLET;ORAL
⤷ Subscribe	⤷ Subscribe	10MG	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

Anatomical Therapeutic Chemical (ATC) Classes for tofacitinib citrate

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	11,253,523	⤷ Subscribe				⤷ Subscribe
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes	RE41783	⤷ Subscribe		Y		⤷ Subscribe
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No	9,937,181	⤷ Subscribe	Y			⤷ Subscribe
Hikma	TOFACITINIB CITRATE	tofacitinib citrate	SOLUTION;ORAL	216878-001	Sep 25, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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

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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	7,091,208	⤷ Subscribe
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	7,265,221	⤷ Subscribe
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	6,956,041	⤷ Subscribe
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	6,956,041	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for tofacitinib citrate

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Country	Patent Number	Title	Estimated Expiration
Australia	2017203334	Tofacitinib oral sustained release dosage forms	⤷ Subscribe
Argentina	095487	FORMA DE DOSIS ORALES DE LIBERACIÓN SOSTENIDA DE TOFACITINIB	⤷ Subscribe
South Africa	200204535	Pyrrolo[2,3-d]pyrimidine compounds.	⤷ Subscribe
Poland	355907		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tofacitinib citrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	2017/036	Ireland	⤷ Subscribe	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	132017000095300	Italy	⤷ Subscribe	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,C1666481	Lithuania	⤷ Subscribe	PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	37/2017	Austria	⤷ Subscribe	PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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