Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
Cerilliant
Harvard Business School
Chubb
Teva
Deloitte
Medtronic
US Army

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021928

« Back to Dashboard

NDA 021928 describes CHANTIX, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from six 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 ten drug master file entries for this compound. Six 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
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
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 N 0069-0468-56
CHANTIX varenicline tartrate TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0469 N 0069-0469-56

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:Dec 16, 2019
Regulatory Exclusivity Use:PROVIDES FOR DATA EVALUATING THE NEUROPSYCHIATRIC SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN SUBJECTS WITH AND WITHOUT A HISTORY OF PSYCHIATRIC DISORDERS
Patent:➤ Try a Free TrialPatent Expiration:May 10, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AID TO SMOKING CESSATION

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
Medtronic
Johnson and Johnson
Chinese Patent Office
Queensland Health
Colorcon
AstraZeneca
Covington

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.