XELJANZ Drug Patent Profile

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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 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
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

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
>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
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
>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
Yugoslavia	41302		⤷ Sign Up
Tunisia	SN03128	RESOLUTION OPTIQUE DE LA (1-BENZYL-4-METHYLPIPERIDINE-3-YL) METHYLAMINE ET SON UTILISATION POUR LA PREPARATION DE DERIVES DE PYRROLO 2,3-PYRIMIDINE SERVANT D'INHIBITEURS DE PROTEINES KINASES	⤷ Sign Up
Peru	10962001		⤷ 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	PA2017025,C1666481	Lithuania	⤷ Sign Up	PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	615	Finland	⤷ Sign Up
1666481	PA2017025	Lithuania	⤷ Sign Up	PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description