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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208246

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NDA 208246 describes XELJANZ XR, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. There are six 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 nine 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 Inc
Ingredient:tofacitinib citrate
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 208246
Mechanism of ActionJanus 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 N 0069-0501-14
XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246 NDA Pfizer Laboratories Div Pfizer Inc 0069-0501 N 0069-0501-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 11MG BASE
Approval Date:Feb 23, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2020
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO METHOTREXATE OR OTHER NON-BIOLOGIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS
Patent:➤ Try a Free TrialPatent Expiration:Dec 8, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 25, 2023Product Flag?Substance Flag?YDelist Request?

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UBS
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Covington
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Deloitte
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Baxter

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