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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203214

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NDA 203214 describes XELJANZ, which is a drug marketed by Pf Prism Cv and Pfizer Inc and is included in two NDAs. It is available from two suppliers. There are six 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 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 NDA: 203214

Formulation / Manufacturing:see details

Pharmacology for NDA: 203214

Mechanism of ActionJanus Kinase Inhibitors

Suppliers and Packaging for NDA: 203214

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tofacitinib citrate
TABLET;ORAL 203214 NDA Pfizer Laboratories Div Pfizer Inc 0069-1001 0069-1001-01 60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01)
tofacitinib citrate
TABLET;ORAL 203214 NDA Pfizer Laboratories Div Pfizer Inc 0069-1001 0069-1001-02 180 TABLET, FILM COATED in 1 BOTTLE (0069-1001-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 6, 2012TE:RLD:Yes
Patent:6,956,041Patent Expiration:Dec 8, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,965,027Patent Expiration:Mar 25, 2023Product Flag?Substance Flag?YDelist Request?
Patent:7,265,221Patent Expiration:Dec 8, 2020Product Flag?Substance Flag?YDelist Request?

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