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Last Updated: April 26, 2024

Varenicline tartrate - Generic Drug Details

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What are the generic drug sources for varenicline tartrate and what is the scope of freedom to operate?

Varenicline tartrate is the generic ingredient in three branded drugs marketed by Oyster Point Pharma, Pf Prism Cv, 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 twelve NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has thirty-four patent family members in eighteen countries.

There are eleven drug master file entries for varenicline tartrate. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for varenicline tartrate

International Patents:	34
US Patents:	6
Tradenames:	3
Applicants:	12
NDAs:	12
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	38
Patent Applications:	337
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for varenicline tartrate
What excipients (inactive ingredients) are in varenicline tartrate?	varenicline tartrate excipients list
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
University of Kansas Medical Center	Phase 3

See all varenicline tartrate clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 0.5MG BASE	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 1MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

Nicotinic Agonists

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	216723-001	Jun 12, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	201962-001	Jan 25, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	211862-001	Dec 4, 2023	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
Avalanche Pharm	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	217283-002	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

International Patents for varenicline tartrate

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Country	Patent Number	Title	Estimated Expiration
Japan	7257371		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2016064759		⤷ Try a Trial
South Africa	201703467	METHODS OF TREATING OCULAR CONDITIONS	⤷ Try a Trial
Australia	2015336216	Methods of treating ocular conditions	⤷ Try a Trial
China	111956803	治疗眼部病状的方法 (Methods of treating ocular conditions)	⤷ Try a Trial
European Patent Office	3848028	MÉTHODES DE TRAITEMENT DE TROUBLES OCULAIRES (METHODS OF TREATING OCULAR CONDITIONS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for varenicline tartrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1044189	08C0039	France	⤷ Try a Trial	PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
1044189	SPC/GB08/034	United Kingdom	⤷ Try a Trial	PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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