CHANTIX Drug Patent Profile

When do Chantix patents expire, and what generic alternatives are available?

Chantix is a drug marketed by Pf Prism Cv and is included in one NDA.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Chantix

A generic version of CHANTIX was approved as varenicline tartrate by ENDO OPERATIONS on August 11^th, 2021.

Summary for CHANTIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	167
Patent Applications:	132
Drug Prices:	Drug price information for CHANTIX
Drug Sales Revenues:	Drug sales revenues for CHANTIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CHANTIX
What excipients (inactive ingredients) are in CHANTIX?	CHANTIX excipients list
DailyMed Link:	CHANTIX at DailyMed

See drug prices for CHANTIX

See drug sales revenues for CHANTIX

Recent Clinical Trials for CHANTIX

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

Sponsor	Phase
Massachusetts General Hospital	Phase 3
Mayo Clinic	Early Phase 1
Duke University	Phase 4

See all CHANTIX clinical trials

Pharmacology for CHANTIX

Drug Class	Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist
Mechanism of Action	Cholinergic Agonists Partial Cholinergic Nicotinic Agonists

Paragraph IV (Patent) Challenges for CHANTIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHANTIX	Tablets	varenicline tartrate	0.5 mg and 1 mg	021928	5	2010-05-10

US Patents and Regulatory Information for CHANTIX

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	021928-001	May 10, 2006		DISCN	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		DISCN	Yes	No

International Patents for CHANTIX

See the table below for patents covering CHANTIX around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	2006016
European Patent Office	1619192	COMPOSES AZAPOLYCYCLIQUES A FUSION ARYLE (ARYL FUSED AZAPOLYCYCLIC COMPOUNDS)
Spain	2246396
Norway	20024042
Bulgaria	108343
Slovakia	9712000	ARYL FUSED AZAPOLYCYCLIC COMPOUNDS

Supplementary Protection Certificates for CHANTIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1044189	PA2008010	Lithuania		PRODUCT NAME: VARENICLINUM TARTRAT; REG. NO/DATE: EU/1/06/360/001-010 20060926
1044189	08C0039	France		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		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	C01044189/01	Switzerland		PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
1044189	300355	Netherlands		300355, 20181113, EXPIRES: 20220425
1044189	CA 2008 00031	Denmark