VARENICLINE TARTRATE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Varenicline Tartrate, and what generic alternatives are available?
Varenicline Tartrate is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Avalanche Pharm, Endo Operations, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, and Zydus. and is included in eleven NDAs.
The generic ingredient in VARENICLINE TARTRATE is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Varenicline Tartrate
A generic version of VARENICLINE TARTRATE was approved as varenicline tartrate by ENDO OPERATIONS on August 11th, 2021.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VARENICLINE TARTRATE?
- What are the global sales for VARENICLINE TARTRATE?
- What is Average Wholesale Price for VARENICLINE TARTRATE?
Summary for VARENICLINE TARTRATE
Recent Clinical Trials for VARENICLINE TARTRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yale University | Phase 2 |
| CTC Bio, Inc. | Phase 1 |
| National Institute on Drug Abuse (NIDA) | Phase 3 |
Pharmacology for VARENICLINE TARTRATE
| Drug Class | Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist |
| Mechanism of Action | Cholinergic Agonists Partial Cholinergic Nicotinic Agonists |
Medical Subject Heading (MeSH) Categories for VARENICLINE TARTRATE
Anatomical Therapeutic Chemical (ATC) Classes for VARENICLINE TARTRATE
Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TYRVAYA | Nasal Spray | varenicline tartrate | 0.03 mg/spray | 213978 | 1 | 2023-04-21 |
| CHANTIX | Tablets | varenicline tartrate | 0.5 mg and 1 mg | 021928 | 5 | 2010-05-10 |
US Patents and Regulatory Information for VARENICLINE TARTRATE
| 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 | |||
| Mankind Pharma | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214255-002 | Aug 1, 2023 | 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 | |||
| Alkem Labs Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214557-002 | Aug 23, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Iii | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214571-002 | Oct 23, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 202019-002 | Feb 28, 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 |
