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Generated: March 21, 2019

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CHANTIX Drug Profile

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Which patents cover Chantix, 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. Eight suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

Drug patent expirations by year for CHANTIX
Generic Entry Opportunity Date for CHANTIX
Generic Entry Date for CHANTIX*:
Constraining patent/regulatory exclusivity:
NDA:
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
Medical Subject Heading (MeSH) Categories for CHANTIX
Synonyms for CHANTIX
(2S,3S)-2,3-dihydroxybutanedioic acid; 5,8,14-triazatetracyclo[10.3.1.0^{2,11}.0^{4,9}]hexadeca-2(11),3,5,7,9-pentaene
(6R,10S)-7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinate
375815-87-5
5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene L-tartrate
6,10-Methano-6H-pyrazino(2,3-h)(3)benzazepine, 7,8,9,10-tetrahydro-, (2R,3R)-2,3-dihydroxybutanedioate (1:1)
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine (2R,3R)-2,3-dihydroxybutanedioate
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine tartrate
7,8,9,10-Tetrahydro-6H-6,10-methanoazepino-[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinate
7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxalin-8-ium (2R,3R)-3-carboxy-2,3-dihydroxypropanoate
7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinate
7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinic acid
7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2S,3S)-2,3-dihydroxysuccinate
7,8,9,10-tetrahydro-6h-6,10-methanoazepino[4,5-g]quinoxaline 2,3-dihydroxybutanedioate(1:1)
815V875
82269ASB48
A21286
AB2000110
AC1L55H3
AC1Q5QUE
AKOS005146509
AKOS025311300
AKOS026750167
AN-6400
AOB5603
API0006308
AS-35136
BC630727
C13H13N3.C4H6O6
CAS-375815-87-5
CCG-221351
Champix
Champix tartrate
Chantix tartrate
Chantix; Champix; CP 526555-18
Chantix;Champix
CHEBI:84507
CHEMBL1201135
CP 526555-18
CP-526,555-18
CP-526555-18
CS-0830
D06282
DSSTox_CID_28998
DSSTox_GSID_49072
DSSTox_RID_83263
DTXSID0049072
FT-0675785
HMS3260I15
HY-10021
I14-8434
LS-186594
MolPort-009-682-971
MolPort-023-220-723
NCGC00260732-01
PubChem18805
PubChem18821
Q-101415
s1440
SB17431
SC-24629
SCHEMBL224852
Tox21_113630
Tox21_500047
TWYFGYXQSYOKLK-LREBCSMRSA-N
UNII-82269ASB48
Varenicline (Tartrate)
varenicline monotartrate
Varenicline tartrate
Varenicline tartrate (JAN/USAN)
Varenicline tartrate [USAN]
Varenicline Tartrate 1.0 mg/ml in Methanol (as free base)
Varenicline tartrate solution, 500 mug/mL in methanol (as free base), ampule of 1 mL, certified reference material
Varenicline tartrate, >=98% (HPLC)
Varenicline Tartrate|375815-87-5|Champix tartrate|Chantix tartrate
X1052
X4690
Z1642292115

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for CHANTIX
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.5 mg and 1 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for CHANTIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 SPC021/2008 Ireland ➤ Sign Up SPC021/2008: 20081105, EXPIRES: 20210925
1044189 C01044189/01 Switzerland ➤ Sign Up PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
1044189 122008000038 Germany ➤ Sign Up PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001-010 20060926
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Moodys
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