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 Alkem Labs Ltd, Apotex, Avalanche Pharm, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Par Pharm Inc, and Zydus. and is included in ten NDAs.
The generic ingredient in VARENICLINE TARTRATE is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-one 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 PAR PHARM INC on August 11th, 2021.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214557-001 | Aug 23, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Par Pharm Inc | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 201785-002 | Aug 11, 2021 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd Iii | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214571-001 | Oct 23, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 201962-002 | Jan 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
