Generic Chantix Availability

Chantix is a brand name of varenicline, approved by the FDA in the following formulation(s):

CHANTIX (varenicline tartrate - tablet;oral)

  • Manufacturer: PFIZER INC
    Approval date: May 10, 2006
    Strength(s): EQ 0.5MG BASE, EQ 1MG BASE [RLD]

Has a generic version of Chantix been approved?

No. There is currently no therapeutically equivalent version of Chantix available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Chantix. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Aryl fused azapolycyclic compounds
    Patent 6,410,550
    Issued: June 25, 2002
    Inventor(s): Jotham Wadsworth; Coe & Paige Roanne Palmer; Brooks
    Assignee(s): Pfizer INC
    Compounds of the formula and their pharmaceutically acceptable salts, wherein R1, R2, and R3 are defined as in the specification, intermediates in the synthesis of such compounds. pharmaceutical compositions containing such compounds and methods of using such compounds, in the treatment of neurological and psychological disorders.
    Patent expiration dates:
    • May 10, 2020
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      Patent use: AID TO SMOKING CESSATION
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  • Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
    Patent 6,890,927
    Issued: May 10, 2005
    Inventor(s): Bogle; David E. & Rose; Peter R. & Williams; Glenn R.
    Assignee(s): Pfizer Inc
    The present invention is directed to the tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene: and pharmaceutical compositions thereof. The present invention in particular is directed to the L-tartrate salt, and further to the various polymorphs of the L-tartrate salt, including two distinct anhydrous polymorphs (referred to herein as Forms A and B) and a hydrate polymorph (referred to herein as Form C). In addition, the present invention is also directed to the D-tartrate salt of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene and the various polymorphs thereof; as well as the D,L-tartrate salt thereof and its polymorphs, and the meso-tartrate salt thereof and its polymorphs.
    Patent expiration dates:
    • May 6, 2022
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      Patent use: AID TO SMOKING CESSATION
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  • Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
    Patent 7,265,119
    Issued: September 4, 2007
    Inventor(s): Bogle; David E. & Williams; Glenn R. & Rose; Peter R.
    Assignee(s): Pfizer Inc
    The present invention is directed to the tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene: and pharmaceutical compositions thereof. The present invention in particular is directed to the L-tartrate salt, and further to the various polymorphs of the L-tartrate salt, including two distinct anhydrous polymorphs (referred to herein as Forms A and B) and a hydrate polymorph (referred to herein as Form C). In addition, the present invention is also directed to the D-tartrate salt of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene and the various polymorphs thereof; as well as the D,L-tartrate salt thereof and its polymorphs, and the meso-tartrate salt thereof and its polymorphs.
    Patent expiration dates:
    • August 3, 2022
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      Patent use: AID TO SMOKING CESSATION
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Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • July 22, 2014 - NEW LANGUAGE ADDED TO CLINICAL STUDIES REGARDING USE IN SMOKERS WITH CARDIOVASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND USE ACCORDING TO AN ALTERNATIVE SET OF DIRECTIONS FOR SETTING A QUIT DATE

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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