VARENICLINE TARTRATE - Generic Drug Details

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What are the generic 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, 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 fifteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has thirty-eight patent family members in nineteen countries.

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

Summary for VARENICLINE TARTRATE

International Patents:	38
US Patents:	10
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	38
Patent Applications:	305
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
National Institute on Drug Abuse (NIDA)	Phase 3

See all VARENICLINE TARTRATE clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 1MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 0.5MG 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

Anatomical Therapeutic Chemical (ATC) Classes for VARENICLINE TARTRATE

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	216723-001	Jun 12, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leading Pharma	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	217151-002	Jul 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leading Pharma	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	217151-001	Jul 25, 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

International Patents for VARENICLINE TARTRATE

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Country	Patent Number	Title	Estimated Expiration
Portugal	3209295		⤷ Sign Up
South Korea	102511955		⤷ Sign Up
Singapore	10202011669P	METHODS OF TREATING OCULAR CONDITIONS	⤷ Sign Up
Finland	3848028		⤷ Sign Up
>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	SPC/GB08/034	United Kingdom	⤷ Sign Up	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
1044189	08C0039	France	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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