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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213082

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NDA 213082 describes XELJANZ, which is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XELJANZ profile page.

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.

Summary for 213082

Tradename:	XELJANZ
Applicant:	Pfizer
Ingredient:	tofacitinib citrate
Patents:	1

Pharmacology for NDA: 213082

Mechanism of Action	Janus Kinase Inhibitors

Suppliers and Packaging for NDA: 213082

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1029	0069-1029-02	1 BOTTLE in 1 CARTON (0069-1029-02) / 240 mL in 1 BOTTLE (0069-1029-01)
XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082	NDA	U.S. Pharmaceuticals	63539-029	63539-029-02	1 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 1MG BASE/ML
Approval Date:	Sep 25, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 21, 2028
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:	Aug 21, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	RE41783*PED	Patent Expiration:	Jun 8, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 213082

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	6,956,041	⤷ Get Started Free
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	7,301,023	⤷ Get Started Free
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	7,265,221	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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