Xeljanz Drug Patent Profile

When do Xeljanz patents expire, and when can generic versions of Xeljanz launch?

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 SLAYBACK PHARMA LLC on September 25^th, 2023.

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:	29
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

See drug prices for Xeljanz

Recent Clinical Trials for Xeljanz

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

Sponsor	Phase
Children's Hospital Los Angeles	Phase 2
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 4
Eli Lilly and Company	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

FDA Regulatory Exclusivity protecting Xeljanz

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				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes			Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No

Expired US Patents for Xeljanz

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

International Patents for Xeljanz

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

Country	Patent Number	Title	Estimated Expiration
Argentina	037635	FORMAS CRISTALINAS Y AMORFAS DE LA SAL MONOCITRATO DE 3-[4-METIL-3-[METIL-(7H-PIRROLO[2,3-D] PIRIMIDIN-4-IL)-AMINO]- PIPERIDIN-1-IL)-3-OXO-PROPIONITRILO, COMPOSICIONES FARMACEUTICAS QUE LO CONTIENEN, USO EN LA MANUFACTURA DE MEDICAMENTOS Y PROCEDIMIENTO PARA OBTENER UNA FORMA CRISTALIZADA
New Zealand	540332	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
Denmark	1666481
Mexico	PA03011062	RESOLUCION OPTICA DE (1-BENCIL-4-METILPIPERIDIN-3-IL)-METILAMINA Y EL USO DE LA MISMA PARA LA PREPARACION DE DERIVADOS DE PIRROLO 2,3-PIRIMIDINA COMO INHIBIDORES DE PROTEINA QUINASAS. (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.)
Estonia	05332	3-{(3R,4R)-4-met l-3-[met l(7H-p rrolo[2,3-d]p rimidiin-4- l)amino]piperidiin-1 - l}-3-oksopropionitriil, selle farmatseutiliselt vastuv?etav sool ja nende kasutamine
South Africa	200307982	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.

Supplementary Protection Certificates for Xeljanz

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	2017/036	Ireland		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	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	PA2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	C201730033	Spain		PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
1666481	LUC00031	Luxembourg		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	C 2017 029	Romania		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