VARENICLINE Drug Patent Profile
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When do Varenicline patents expire, and what generic alternatives are available?
Varenicline is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Dr Reddys, Hetero Labs Ltd Iii, Kanchan Hlthcare, Lupin, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Ne Rx Pharma, Ph Health, Pharmobedient, Piramal, Regcon Holdings, Rhodes Pharms, Shilpa, Umedica, Viwit Pharm, and Zydus. and is included in twenty-one NDAs.
The generic ingredient in VARENICLINE is varenicline tartrate. There are twelve drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Varenicline
A generic version of VARENICLINE was approved as varenicline tartrate by PH HEALTH on August 11th, 2021.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for VARENICLINE?
- What are the global sales for VARENICLINE?
- What is Average Wholesale Price for VARENICLINE?
Summary for VARENICLINE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 21 |
| Drug Prices: | Drug price information for VARENICLINE |
| Drug Sales Revenues: | Drug sales revenues for VARENICLINE |
| DailyMed Link: | VARENICLINE at DailyMed |
Recent Clinical Trials for VARENICLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | PHASE4 |
| Brown University | PHASE2 |
| Brigham and Women's Hospital | PHASE4 |
Anatomical Therapeutic Chemical (ATC) Classes for VARENICLINE
US Patents and Regulatory Information for VARENICLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 216723-001 | Jun 12, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Regcon Holdings | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 219106-002 | Oct 29, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Pharmobedient | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 202019-002 | Feb 28, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Rhodes Pharms | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 213268-001 | May 21, 2025 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
