VARENICLINE TARTRATE Drug Patent Profile
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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, 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 TARTRATE 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 Tartrate
A generic version of VARENICLINE TARTRATE was approved as varenicline tartrate by ENDO OPERATIONS on August 11th, 2021.
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Questions you can ask:
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Summary for VARENICLINE TARTRATE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 38 |
| Patent Applications: | 140 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VARENICLINE TARTRATE |
| DailyMed Link: | VARENICLINE TARTRATE at DailyMed |
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 | |||
| 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 | |||
| Alkem Labs Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214557-002 | Aug 23, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 201785-002 | Aug 11, 2021 | AB | RX | No | Yes | ⤷ 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
