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, Avalanche Pharm, Dr Reddys, Endo Operations, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Piramal, and Zydus. and is included in thirteen NDAs.
The generic ingredient in VARENICLINE is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-four 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 ENDO OPERATIONS on August 11th, 2021.
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- What is the 5 year forecast for VARENICLINE?
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Summary for VARENICLINE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Prices: | Drug price information for VARENICLINE |
| Drug Sales Revenues: | Drug sales revenues for VARENICLINE |
| DailyMed Link: | VARENICLINE at DailyMed |
See drug prices for VARENICLINE
Recent Clinical Trials for VARENICLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| Pradeesh Sivapalan | Phase 4 |
| Westat | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 213019-001 | Mar 19, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 211862-002 | Dec 4, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Piramal | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 217115-002 | Jul 23, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Avalanche Pharm | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 217283-001 | Mar 6, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
