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Last Updated: December 14, 2024

Varenicline - Generic Drug Details

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Summary for varenicline

US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	277
Patent Applications:	3,591
Drug Prices:	Drug price trends for varenicline
Drug Sales Revenues:	Drug sales revenues for varenicline
What excipients (inactive ingredients) are in varenicline?	varenicline excipients list
DailyMed Link:	varenicline at DailyMed

Drug Prices for varenicline

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Drug Sales Revenue Trends for varenicline

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Recent Clinical Trials for varenicline

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
Pradeesh Sivapalan	Phase 4
Westat	N/A

See all varenicline clinical trials

Generic filers with tentative approvals for VARENICLINE

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

Anatomical Therapeutic Chemical (ATC) Classes for varenicline

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

US Patents and Regulatory Information for varenicline

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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
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Ajanta Pharma Ltd	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	213019-002	Mar 19, 2024	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Endo Operations	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	201785-001	Aug 11, 2021	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hetero Labs Ltd Iii	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	214571-001	Oct 23, 2023	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	11,903,941	⤷ Subscribe				⤷ Subscribe
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	11,224,598	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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