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, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Par Pharm Inc, 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 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 |
University of Kansas Medical Center | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 202019-002 | Feb 28, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Avalanche Pharm | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 217283-001 | Mar 6, 2024 | 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 |