Varenicline Tartrate Patent Expiration

Varenicline Tartrate is Used for treating dry eye disease symptoms. It was first introduced by Pf Prism Cv in its drug Chantix on May 10, 2006. Another drug containing Varenicline Tartrate is Tyrvaya. 13 different companies have introduced drugs containing Varenicline Tartrate.


Varenicline Tartrate Patents

Given below is the list of patents protecting Varenicline Tartrate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Chantix US6410550 Aryl fused azapolycyclic compounds May 10, 2020

(Expired)

Pf Prism Cv
Chantix US6410550

(Pediatric)

Aryl fused azapolycyclic compounds Nov 10, 2020

(Expired)

Pf Prism Cv
Chantix 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 06, 2022

(Expired)

Pf Prism Cv
Chantix 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 06, 2022

(Expired)

Pf Prism Cv
Chantix 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 03, 2022

(Expired)

Pf Prism Cv
Chantix 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 03, 2023

(Expired)

Pf Prism Cv
Tyrvaya US10456396 Dry eye treatments Oct 19, 2035 Oyster Point Pharma
Tyrvaya US11224598 Methods of increasing lacrimal proteins Oct 19, 2035 Oyster Point Pharma
Tyrvaya US11903941 Compositions and use of varenicline for treating dry eye Oct 19, 2035 Oyster Point Pharma
Tyrvaya US11903942 Compositions and use of varenicline for treating dry eye Oct 19, 2035 Oyster Point Pharma
Tyrvaya US11903943 Compositions and use of varenicline for treating dry eye Oct 19, 2035 Oyster Point Pharma
Tyrvaya US11911380 Compositions and use of varenicline for treating dry eye Oct 19, 2035 Oyster Point Pharma
Tyrvaya US9504644 Methods of increasing tear production Oct 19, 2035 Oyster Point Pharma
Tyrvaya US9504645 Pharmaceutical formulations for treating ocular conditions Oct 19, 2035 Oyster Point Pharma
Tyrvaya US9532944 Methods of improving ocular discomfort Oct 19, 2035 Oyster Point Pharma
Tyrvaya US9597284 Dry eye treatments Oct 19, 2035 Oyster Point Pharma


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 Varenicline Tartrate's patents.

Given below is the list recent legal activities going on the following patents of Varenicline Tartrate.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jun, 2024 US9532944
Patent eCofC Notification 04 Jun, 2024 US11903942
Email Notification 04 Jun, 2024 US11903942
Recordation of Patent eCertificate of Correction 04 Jun, 2024 US11903942
Mail Patent eCofC Notification 04 Jun, 2024 US11903942
Payment of Maintenance Fee, 8th Year, Large Entity 21 May, 2024 US9504645
Payment of Maintenance Fee, 8th Year, Large Entity 21 May, 2024 US9504644
Post Issue Communication - Certificate of Correction 15 May, 2024 US11903942
Patent eGrant Notification 27 Feb, 2024 US11911380
Mail Patent eGrant Notification 27 Feb, 2024 US11911380



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Varenicline Tartrate Generics

Several generic applications have been filed for Varenicline Tartrate. The first generic version for Varenicline Tartrate was by Endo Operations Ltd and was approved on Aug 11, 2021. And the latest generic version is by Ajanta Pharma Ltd and was approved on Mar 19, 2024.

Given below is the list of companies who have filed for Varenicline Tartrate generic.


1. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Feb 28, 2024
EQ 1MG BASE tablet Prescription ORAL AB Feb 28, 2024


2. AVALANCHE PHARM

Avalanche Pharmaceutical Llc has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Avalanche Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Mar 6, 2024
EQ 1MG BASE tablet Prescription ORAL AB Mar 6, 2024


3. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE tablet Prescription ORAL AB Dec 4, 2023
EQ 0.5MG BASE tablet Prescription ORAL AB Dec 4, 2023


4. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Oct 23, 2023
EQ 1MG BASE tablet Prescription ORAL AB Oct 23, 2023


5. ZYDUS

Zydus Worldwide Dmcc has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Zydus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Jun 12, 2023
EQ 1MG BASE tablet Prescription ORAL AB Jun 12, 2023


6. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE tablet Prescription ORAL AB Mar 19, 2024
EQ 0.5MG BASE tablet Prescription ORAL AB Mar 19, 2024


7. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Aug 11, 2021
EQ 1MG BASE

(reference standard)

tablet Prescription ORAL AB Aug 11, 2021


8. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Aug 23, 2023
EQ 1MG BASE tablet Prescription ORAL AB Aug 23, 2023


9. MANKIND PHARMA

Mankind Pharma Ltd has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Aug 1, 2023
EQ 1MG BASE tablet Prescription ORAL AB Aug 1, 2023


10. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE tablet Prescription ORAL AB Jan 25, 2023
EQ 0.5MG BASE tablet Prescription ORAL AB Jan 25, 2023


11. LEADING PHARMA

Leading Pharma Llc has filed for 2 different strengths of generic version for Varenicline Tartrate. Given below are the details of the strengths of this generic introduced by Leading Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE tablet Prescription ORAL AB Jul 25, 2023
EQ 1MG BASE tablet Prescription ORAL AB Jul 25, 2023