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. 20 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.
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
Drugs Generating Over $1 Billion in Annual Revenue
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NCE-1 Patent Expiry in the Next 1 Year
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Recently Granted Patents in EP
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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 Viwit Pharmaceutical Co Ltd and was approved on May 6, 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 0.5MG BASE
tablet
Prescription
ORAL
AB
Mar 19, 2024
EQ 1MG 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
Aurangabad
Ajanta Pharma Ltd.
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
Weston
Apotex Corp.
Canada
Winnipeg
Apotex Fermentation Inc.
Toronto
Apotex Inc.
Richmond Hill
Apotex Inc.
North York
Apotex Inc.
Etobicoke
Apotex, Inc.
Brantford
Apotex Pharmachem Inc.
India
Bangalore
Apotex Research Private Limited - Bioequivalence Centre
Bengaluru
Apotex Research Private Limited
Bangalore
Apotex Pharmachem India Pvt Ltd.
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
Sangareddy
Aurobindo Pharma Limited
Medchal
Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar
Aurobindo Pharma Limited
Bachupally
Aurobindo Pharma Limited
United States
East Windsor
Aurobindo Pharma USA Inc
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. 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
8. 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
Taluka Khalapur, District Raigad
Indoco Remedies Limited
Navi Mumbai
Indoco Remedies Limited
Verna
Indoco Remedies Limited
Verna
Indoco Remedies Limited (Plant I)
9. 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
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
Aurangabad
Lupin Ltd.
10. 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 1MG BASE
tablet
Prescription
ORAL
AB
Dec 9, 2024
EQ 0.5MG BASE
tablet
Prescription
ORAL
AB
Dec 9, 2024
11. 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 1MG BASE
tablet
Prescription
ORAL
AB
Aug 1, 2023
EQ 0.5MG 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
Imt Manesar
Mankind Pharma Limited
Paonta Sahib
Mankind Pharma Limited
12. 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
13. 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
Manufacturing Plant Locations
New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
Country
City
Firm Name
United States
Rockford
Mylan Institutional, Inc.
Saint Albans
Mylan Technologies, Inc.
San Carlos
Mylan Pharmaceuticals Inc.
Morgantown
Mylan Specialty, L.P.
Santa Barbara
Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Greensboro
Mylan Pharmaceuticals Inc
Morgantown
MYLAN CONSUMER HEALTHCARE Inc.
India
Sarigam
Mylan Laboratories Limited
Hosur
Mylan Laboratories Limited
Anekal Taluk, Bangalore
Mylan Laboratories Limited
Bangalore
Mylan Laboratories Limited
Aurangabad
Mylan Laboratories Limited (FDF-2)
Hyderabad
Mylan Laboratories Limited
Sinnar
Mylan Laboratories Limited
Pithampur, District Dhar
Mylan Laboratories Limited
Canada
Etobicoke
Mylan Pharmaceuticals ULC
Ireland
Inverin
Mylan Teoranta
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 1MG BASE
tablet
Prescription
ORAL
AB
Mar 6, 2024
EQ 0.5MG BASE
tablet
Prescription
ORAL
AB
Mar 6, 2024
15. 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
16. 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 1MG BASE
tablet
Prescription
ORAL
AB
Apr 8, 2025
EQ 0.5MG 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
Minneapolis
Shilpa Gupta
India
Chicksugur, Raichur
Shilpa Pharma Lifesciences Limited
Polepally, Jadcherla
Shilpa Medicare Limited
Hyderbad
Shilpa Medicare Limited
Hyderabad
Shilpa Medicare Limited
Bengaluru
Shilpa Medicare Limited
17. 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 0.5MG BASE
tablet
Prescription
ORAL
AB
May 6, 2025
EQ 1MG 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
Tengzhou
Viwit Pharmaceutical Co., Ltd.
18. 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.
