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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-two patent family members in fifty-six countries.

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

Summary for CHANTIX

International Patents:	182
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	8
Bulk Api Vendors:	65
Clinical Trials:	66
Patent Applications:	4
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CHANTIX
DailyMed Link:	CHANTIX at DailyMed

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.

Pharmacology for CHANTIX

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

Medical Subject Heading (MeSH) Categories for CHANTIX

Nicotinic Agonists

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	Y
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		RX	Yes	Yes			Y	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	021928-002	May 10, 2006		RX	Yes	Yes			Y	Y

Paragraph IV (Patent) Challenges for CHANTIX

Drugname	Dosage	Strength	RLD	Date
	Tablets	0.5 mg and 1 mg

International Patents for CHANTIX

Country	Document Number	Estimated Expiration
Netherlands	300355
Georgia, Republic of	P20053712
Eurasian Patent Organization	003190
Estonia	200200475

Supplementary Protection Certificates for CHANTIX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
2008000038	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
2008010,C1044189	Lithuania		PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
1044189/01	Switzerland		PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006