Varenicline Tartrate Patent Expiration
Varenicline Tartrate is Used for treating dry eye disease symptoms. It was first introduced by Pf Prism Cv
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 |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 | 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 |
US6410550 (Pediatric) | Aryl fused azapolycyclic compounds |
Nov 10, 2020
(Expired) | Pf Prism Cv |
| Chantix | US6410550 | Aryl fused azapolycyclic compounds |
May 10, 2020
(Expired) | Pf Prism Cv |
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.
Latest Legal Activities on Varenicline Tartrate's Patents
Given below is the list recent legal activities going on the following patents of Varenicline Tartrate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jun, 2024 | US9532944 |
| Patent eCofC Notification | 04 Jun, 2024 | US11903942 |
| Email Notification Critical | 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 |
Varenicline Tartrate's Family Patents
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Varenicline Tartrate Generic API Manufacturers
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 Handa Pharmaceuticals Llc and was approved on May 21, 2025.
Given below is the list of companies who have filed for Varenicline Tartrate generic, along with the locations of their manufacturing plants worldwide.
1. 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 |
Manufacturing Plant Locations New
Ajanta Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Ajanta Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
2. 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 1MG BASE | tablet | Prescription | ORAL | AB | Aug 23, 2023 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Aug 23, 2023 |
3. 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 0.5MG BASE | tablet | Prescription | ORAL | AB | Jan 25, 2023 |
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Jan 25, 2023 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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4. AUROBINDO PHARMA
Aurobindo 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 Aurobindo Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | May 2, 2025 |
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | May 2, 2025 |
Manufacturing Plant Locations New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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5. DR REDDYS
Dr Reddys 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 Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Oct 1, 2024 |
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Oct 1, 2024 |
6. 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 1MG BASE
(reference standard) | tablet | Prescription | ORAL | AB | Aug 11, 2021 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Aug 11, 2021 |
7. HANDA PHARMS LLC
Handa Pharmaceuticals 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 Handa Pharms Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | May 21, 2025 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | May 21, 2025 |
8. 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 1MG BASE | tablet | Prescription | ORAL | AB | Oct 23, 2023 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Oct 23, 2023 |
9. INDOCO
Indoco Remedies 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 Indoco.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Oct 29, 2024 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Oct 29, 2024 |
Manufacturing Plant Locations New
Indoco's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Indoco as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||
10. 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 0.5MG BASE | tablet | Prescription | ORAL | AB | Dec 4, 2023 |
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Dec 4, 2023 |
Manufacturing Plant Locations New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
11. MACLEODS PHARMS LTD
Macleods Pharmaceuticals 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 Macleods Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Dec 9, 2024 |
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Dec 9, 2024 |
12. 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 |
Manufacturing Plant Locations New
Mankind Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Mankind Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
| |||||
13. MEDLEY PHARMS
Medley Pharmaceuticals 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 Medley Pharms.
| 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 |
14. NE RX PHARMA
Ne Rx 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 Ne Rx Pharma.
| 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 |
15. NORVIUM BIOSCIENCE
Norvium Bioscience 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 Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Feb 28, 2024 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Feb 28, 2024 |
16. PIRAMAL
Piramal Healthcare Uk 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 Piramal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1MG BASE | tablet | Discontinued | ORAL | N/A | Jul 23, 2024 |
| EQ 0.5MG BASE | tablet | Discontinued | ORAL | N/A | Jul 23, 2024 |
17. SHILPA
Shilpa Medicare 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 Shilpa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Apr 8, 2025 |
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | Apr 8, 2025 |
Manufacturing Plant Locations New
Shilpa's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Shilpa as present at those locations.
| Country | City | Firm Name | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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18. VIWIT PHARM
Viwit Pharmaceutical Co 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 Viwit Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1MG BASE | tablet | Prescription | ORAL | AB | May 6, 2025 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | May 6, 2025 |
Manufacturing Plant Locations New
Viwit Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Viwit Pharm as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| China |
| |||
19. 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 1MG BASE | tablet | Prescription | ORAL | AB | Jun 12, 2023 |
| EQ 0.5MG BASE | tablet | Prescription | ORAL | AB | Jun 12, 2023 |
Manufacturing Plant Locations New
Zydus's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Zydus as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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