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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021928

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NDA 021928 describes CHANTIX, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from five suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CHANTIX profile page.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
Summary for 021928
Tradename:CHANTIX
Applicant:Pf Prism Cv
Ingredient:varenicline tartrate
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021928
Generic Entry Date for 021928*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021928
Medical Subject Heading (MeSH) Categories for 021928
Suppliers and Packaging for NDA: 021928
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHANTIX varenicline tartrate TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0468 0069-0468-56 56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56)
CHANTIX varenicline tartrate TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0469 0069-0469-03 1 BLISTER PACK in 1 CARTON (0069-0469-03) > 56 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021928
Tradename Dosage Ingredient NDA Submissiondate
CHANTIX TABLET;ORAL varenicline tartrate 021928 2010-05-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 10, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 12, 2019
Regulatory Exclusivity Use:CHANGES TO THE DOSAGE AND ADMINISTRATION AND CLINICAL STUDIES SECTIONS OF THE LABELING TO SUPPORT THE REDUCE-TO-QUIT PARADIGM
Regulatory Exclusivity Expiration:Feb 22, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO LABELING TO DESCRIBE A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN ADOLESCENT SMOKERS
Regulatory Exclusivity Expiration:Aug 22, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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