XELJANZ Drug Patent Profile

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When do Xeljanz patents expire, and what generic alternatives are available?

Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-five patent family members in fifty-two countries.

The generic ingredient in XELJANZ is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xeljanz

A generic version of XELJANZ was approved as tofacitinib citrate by HIKMA on September 25^th, 2023.

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Summary for XELJANZ

International Patents:	75
US Patents:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	30
Patent Applications:	106
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XELJANZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELJANZ
What excipients (inactive ingredients) are in XELJANZ?	XELJANZ excipients list
DailyMed Link:	XELJANZ at DailyMed

Drug patent expirations by year for XELJANZ

Recent Clinical Trials for XELJANZ

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

Sponsor	Phase
Takeda	Phase 4
Children's Hospital Los Angeles	Phase 2
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 4

See all XELJANZ clinical trials

Pharmacology for XELJANZ

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for XELJANZ

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 XELJANZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XELJANZ	Oral Solution	tofacitinib citrate	1 mg/mL	213082	1	2021-11-12
XELJANZ	Tablets	tofacitinib citrate	10 mg	203214	1	2019-07-24
XELJANZ	Tablets	tofacitinib citrate	5 mg	203214	3	2016-11-07

US Patents and Regulatory Information for XELJANZ

XELJANZ is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting XELJANZ

Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting XELJANZ

TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION
Exclusivity Expiration: ⤷ Sign Up

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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	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 XELJANZ

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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	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	⤷ Sign Up	⤷ Sign Up
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	⤷ Sign Up	⤷ Sign Up
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for XELJANZ

See the table below for patents covering XELJANZ around the world.

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Country	Patent Number	Title	Estimated Expiration
Georgia, Republic of	P20063784	Optical Resolution of (1-Benzyl-4- Methylpiperidin-3-Yl) -Methylamine Enantiomers and Use Thereof for Preparation of Pyrrolo 2,3-Pyrimidine Derivatives as Protein Kinases Inhibitors	⤷ Sign Up
Spain	2295495		⤷ Sign Up
South Korea	20060133117		⤷ Sign Up
Czech Republic	20033260		⤷ Sign Up
Australia	2008203170		⤷ Sign Up
Eurasian Patent Organization	012666	ОПТИЧЕСКОЕ РАЗДЕЛЕНИЕ (1-БЕНЗИЛ-4-МЕТИЛПИПЕРИДИН-3-ИЛ)МЕТИЛАМИНА И ЕГО ПРИМЕНЕНИЕ ДЛЯ ПОЛУЧЕНИЯ ПРОИЗВОДНЫХ ПИРРОЛО 2,3-ПИРИМИДИНА В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ (OPTICAL RESOLUTION OF (1-BENZYL-4-METHYLPIPERIDIN-3-YL)-METHYLAMINE AND THE USE THEREOF FOR THE PREPARATION OF PYRROLO 2,3-PYRIMIDINE DERIVATIVES AS PROTEIN KINASES INHIBITORS)	⤷ Sign Up
Germany	60007552		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for XELJANZ

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	C 2017 029	Romania	⤷ Sign Up	PRODUCT NAME: TOFACITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA CITRAT 3-((3R,4R)-4-METIL-3-{METIL-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-AMINO]PERIDINIL)-3-OXO-PROPIONITRIL; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF NATIONAL AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
1666481	CA 2017 00035	Denmark	⤷ Sign Up	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	132017000095300	Italy	⤷ Sign Up	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	2017/036	Ireland	⤷ Sign Up	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	2017C/032	Belgium	⤷ Sign Up	PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481	300887	Netherlands	⤷ Sign Up	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	CR 2017 00035	Denmark	⤷ Sign Up	PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description