Details for New Drug Application (NDA): 208246

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NDA 208246 describes XELJANZ XR, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XELJANZ XR profile page.

The generic ingredient in XELJANZ XR 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 208246

Tradename:	XELJANZ XR
Applicant:	Pfizer
Ingredient:	tofacitinib citrate
Patents:	4

Pharmacology for NDA: 208246

Mechanism of Action	Janus Kinase Inhibitors

Suppliers and Packaging for NDA: 208246

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0501	0069-0501-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30)
XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0502	0069-0502-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 11MG BASE
Approval Date:	Feb 23, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 14, 2024
Regulatory Exclusivity Use:	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
Patent:	⤷ Sign Up	Patent Expiration:	Mar 14, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98
Patent:	⤷ Sign Up	Patent Expiration:	Mar 14, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98

Expired US Patents for NDA 208246

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019	⤷ Sign Up	⤷ Sign Up
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019	⤷ Sign Up	⤷ Sign Up
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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