XELJANZ Drug Patent Profile

Which patents cover Xeljanz, 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 five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and nine patent family members in fifty-four 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^® Generic Entry Outlook for Xeljanz

Xeljanz was eligible for patent challenges on November 6, 2016.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tofacitinib citrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XELJANZ

International Patents:	109
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	28
Patent Applications:	151
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
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 4
University of Alabama at Birmingham	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

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 two US patents and three FDA Regulatory Exclusivities.

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

Expired US Patents for XELJANZ

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

International Patents for XELJANZ

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

Country	Patent Number	Title	Estimated Expiration
Australia	1295001
Denmark	1666481
African Intellectual Property Organization (OAPI)	12118	PyrroloÄ2,3-dÜpyrimidine compounds.
Iceland	6383
New Zealand	530380	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	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
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	2017C/032	Belgium		PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481	615	Finland
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