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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
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, 8 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, 11 months 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
(2 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
|
|
US6410550 (Pediatric) | Aryl fused azapolycyclic compounds |
Nov, 2020
(3 years ago) |
Expired
|
| US6410550 | Aryl fused azapolycyclic compounds |
May, 2020
(4 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Chantix's patents.
Latest Legal Activities on Chantix's Patents
Given below is the list of recent legal activities going on the following patents of Chantix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Termination or Final Written Decision | 29 Oct, 2021 | US6890927 |
| Petition Requesting Trial | 17 Jun, 2021 | US6890927 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2019 | US7265119 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Jan, 2011 | US7265119 |
| Email Notification Critical | 20 Jan, 2011 | US7265119 |
| Correspondence Address Change Critical | 18 Jan, 2011 | US7265119 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Dec, 2010 | US6890927 |
| Email Notification Critical | 29 Dec, 2010 | US6890927 |
| Correspondence Address Change Critical | 27 Dec, 2010 | US6890927 |
| Post Issue Communication - Certificate of Correction | 18 Mar, 2008 | US7265119 |
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 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 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 |
|---|---|---|---|---|
 | ||||
| US6890927 | June, 2021 |
Terminated-Settled
(29 Oct, 2021) | 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Varenicline Tartrate is the generic name for the brand Chantix. 13 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 |
Alternative Brands for Chantix
Chantix which is used for smoking cessation., has several other brand drugs using the same active ingredient (Varenicline Tartrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Oyster Point Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Varenicline Tartrate, Chantix's active ingredient. Check the complete list of approved generic manufacturers for Chantix
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.
Approval 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 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |