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CHANTIX Drug Profile

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-three patent family members in fifty-seven countries.

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

US ANDA Litigation and Generic Entry Outlook for Chantix

Chantix was eligible for patent challenges on May 10, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2023. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $474mm indicating the motivation for generic entry.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (varenicline tartrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for CHANTIX

International Patents:	183
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	75
Clinical Trials:	86
Patent Applications:	4
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
DailyMed Link:	CHANTIX at DailyMed

See drug prices for CHANTIX

See drug sales revenues for CHANTIX

Generic Entry Opportunity Date for CHANTIX

NDA:

021928

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHANTIX

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

Sponsor	Phase
Joseph Valentino, MD	Phase 2
Vanderbilt-Ingram Cancer Center	Phase 3
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

Paragraph IV (Patent) Challenges for CHANTIX

Tradename	Dosage	Ingredient	NDA	Submissiondate
CHANTIX	TABLET;ORAL	varenicline tartrate	021928	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		RX	Yes	No					Y
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006		RX	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006		RX	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		RX	Yes	Yes
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		RX	Yes	Yes					Y
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		RX	Yes	Yes
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006		RX	Yes	No					Y

International Patents for CHANTIX

Country	Patent Number	Estimated Expiration
Japan	2004533446
Denmark	1259489
Slovakia	12042002
Singapore	102686
Ukraine	66825
Australia	9641698
Malaysia	118163

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	91442	Luxembourg		91442, EXPIRES: 20210926
1044189	325	Finland
1044189	122008000038	Germany		PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION 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	C01044189/01	Switzerland		PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
1044189	SPC021/2008	Ireland		SPC021/2008: 20081105, EXPIRES: 20210925