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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
Fuji
UBS
Boehringer Ingelheim
Accenture
Johnson and Johnson
Baxter
Cantor Fitzgerald
Teva

Generated: January 18, 2018

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 203214
Tradename:XELJANZ
Applicant:Pf Prism Cv
Ingredient:tofacitinib citrate
Patents:6
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
XELJANZ tofacitinib citrate TABLET;ORAL 203214 NDA Pfizer Laboratories Div Pfizer Inc 0069-1001 0069-1001-03 28 TABLET, FILM COATED in 1 BOTTLE (0069-1001-03)
XELJANZ 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 6, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 21, 2017
Regulatory Exclusivity Use:ADDITION OF INFORMATION TO THE CLINICAL STUDIES - RADIOGRAPHIC RESPONSE SECTION OF THE PACKAGE INSERT
Regulatory Exclusivity Expiration:Nov 6, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ SubscribePatent Expiration:Dec 8, 2020Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Cipla
Queensland Health
Merck
Boehringer Ingelheim
Fish and Richardson
US Army
Argus Health
Healthtrust
US Department of Justice

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. thinkBiotech performs no independent verifification 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.

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