Chantix Patent Expiration

Chantix is a drug owned by Pf Prism Cv. It is protected by 6 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2023. Details of Chantix's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6410550 Aryl fused azapolycyclic compounds
May, 2020

(4 years ago)

Expired
US6410550

(Pediatric)

Aryl fused azapolycyclic compounds
Nov, 2020

(3 years ago)

Expired
US6890927 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
May, 2022

(2 years ago)

Expired
US7265119 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
Aug, 2022

(1 year, 11 months ago)

Expired
US6890927

(Pediatric)

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
Nov, 2022

(1 year, 8 months ago)

Expired
US7265119

(Pediatric)

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
Feb, 2023

(1 year, 5 months ago)

Expired


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Chantix and ongoing litigations to help you estimate the early arrival of Chantix generic.

Chantix's Litigations

Chantix has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 17, 2021, against patent number US6890927. The petitioner Apotex Inc. et al., challenged the validity or infringement of this patent, with Pfizer Inc. as the respondent. Click below to track the latest information on how companies are challenging Chantix's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6890927 June, 2021 Terminated-Settled Pfizer Inc. Apotex Inc. et al.


FDA has granted some exclusivities to Chantix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Chantix, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Chantix.

Exclusivity Information

Chantix holds 7 exclusivities. All of its exclusivities have expired in 2022. Details of Chantix's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-105) Jul 22, 2014
M(M-143) Oct 15, 2017
M(M-144) Oct 15, 2017
M(M-183) Aug 12, 2019
M(M-192) Dec 16, 2019
M(M-237) Feb 22, 2022
Pediatric Exclusivity(PED) Aug 22, 2022

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Chantix is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Chantix's family patents as well as insights into ongoing legal events on those patents.

Chantix's family patents

Chantix has patent protection in a total of 48 countries. It's US patent count contributes only to 5.9% of its total global patent coverage. 44 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Chantix.

Family Patents

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Generic Launch

Generic Release Date:

Chantix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 03, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Chantix Generics:

Varenicline Tartrate is the generic name for the brand Chantix. 11 different companies have already filed for the generic of Chantix, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Chantix's generic

How can I launch a generic of Chantix before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Chantix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Chantix's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Chantix -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.5 mg and 1 mg 10 May, 2010 5 11 Aug, 2021 03 Aug, 2022 Deferred




About Chantix

Chantix is a drug owned by Pf Prism Cv. It is used for smoking cessation. Chantix uses Varenicline Tartrate as an active ingredient. Chantix was launched by Pf Prism Cv in 2006.

Market Authorisation Date:

Chantix was approved by FDA for market use on 10 May, 2006.

Active Ingredient:

Chantix uses Varenicline Tartrate as the active ingredient. Check out other Drugs and Companies using Varenicline Tartrate ingredient

Treatment:

Chantix is used for smoking cessation.

Dosage:

Chantix is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL