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XELJANZ Drug Profile

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

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

This drug has one hundred and eighty-five patent family members in fifty-seven countries.

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

Summary for XELJANZ

International Patents:	185
US Patents:	7
Applicants:	2
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	40
Clinical Trials:	6
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XELJANZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELJANZ
DailyMed Link:	XELJANZ at DailyMed

Generic Entry Opportunity Date for XELJANZ

NDA:

203214

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for XELJANZ

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

US Patents and Regulatory Information for XELJANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	Yes
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	Yes			Y
Pfizer Inc	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	Yes
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	Yes				Y

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Paragraph IV (Patent) Challenges for XELJANZ

Drugname	Dosage	Strength	RLD	Date
	Tablets	5 mg
	Extended-release Tablets	11 mg

Non-Orange Book US Patents for XELJANZ

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,432,370	Chiral salt resolution
6,627,754	Pyrrolo[2,3-d]pyrimidine compounds
7,803,805	Cristalline 3-{(3R,4R)-4 methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}- -3-oxo-propionitrile mono citrate salt
7,601,727	Pyrrolo[2,3-d]pyrimidine compounds

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International Patents for XELJANZ

Country	Document Number	Estimated Expiration
Germany	60037345
Estonia	05351
Panama	8546301
Yugoslavia	41302

Supplementary Protection Certificates for XELJANZ

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017000062	Germany		PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1235830/01	Switzerland		PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
2017 00035	Denmark		PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322