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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty-eight countries.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Six 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 PAR PHARM INC on August 11^th, 2021.

Summary for CHANTIX

International Patents:	61
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	165
Patent Applications:	202
Formulation / Manufacturing:	see details
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
Mayo Clinic	Early Phase 1
Duke University	Phase 4
Medical University of South Carolina	Phase 1/Phase 2

See all CHANTIX clinical trials

Pharmacology for CHANTIX

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

Anatomical Therapeutic Chemical (ATC) Classes for CHANTIX

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

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

CHANTIX is protected by two US patents and two FDA Regulatory Exclusivities.

Patents protecting CHANTIX

FDA Regulatory Exclusivity protecting 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	AB	RX	Yes	No					Y
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006	AB	RX	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006	AB	RX	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006	AB	RX	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006	AB	RX	Yes	No					Y

International Patents for CHANTIX

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA03010364	SALES TARTRATO DE 5,8,14-TRIAZATETRACICLO (10.3.1.02,11.04,9) HEXADECA-2(11),3,5,7,9-PENTAENO Y COMPOSICIONES FARMACEUTICAS DE LAS MISMAS. (TARTRATE SALTS OF 5,8,14-TRIAZATETRACYCLO {10.3.1.02.)
South Korea	100537976
Iceland	6957
Portugal	1392307
European Patent Office	1392307	SELS DE TARTRATE DE 5,8,14-TRIAZATETRACYCLO 10.3.1.02,11.04,9]-HEXADECA-2(11),3,5,7,9-PENTAENE (TARTRATE SALTS OF 5,8,14-TRIAZATETRACYCLO[10.3.1.02,11.04,9]-HEXADECA-2(11),3,5,7,9-PENTAENE)

Supplementary Protection Certificates for CHANTIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1044189	PA2008010,C1044189	Lithuania		PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
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	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	91442	Luxembourg		91442, EXPIRES: 20210926
1044189	325	Finland