Last Updated: August 3, 2026

Details for New Drug Application (NDA): 213082

✉ Email this page to a colleague

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. Twenty-one 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:	AA	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:	⤷ Start Trial	Patent Expiration:	Jun 8, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 213082

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	⤷ Start Trial	⤷ Start Trial
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	⤷ Start Trial	⤷ Start Trial
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.