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Last Updated: November 14, 2019

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Varenicline tartrate - Generic Drug Details

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What are the generic drug sources for varenicline tartrate and what is the scope of patent protection?

Varenicline tartrate is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has one hundred and eighty-three patent family members in fifty-seven countries.

There are twelve drug master file entries for varenicline tartrate. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for varenicline tartrate

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

SponsorPhase
University of Kansas Medical CenterPhase 3
University of ChicagoPhase 4
Centre for Addiction and Mental HealthPhase 2

See all varenicline tartrate clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 1MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 0.5MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for varenicline tartrate
Medical Subject Heading (MeSH) Categories for varenicline tartrate
Synonyms for varenicline tartrate
(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 (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
AC-8849
AC1L55H3
AC1Q5QUE
AKOS005146509
AKOS025311300
AKOS025402398
AKOS026750167
AKOS030228787
AN-6400
AOB5603
API0006308
AS-35136
BC630727
BCP04198
C13H13N3.C4H6O6
CAS-375815-87-5
CCG-221351
Champix
Champix tartrate
Chantix
Chantix tartrate
Chantix; Champix; CP 526555-18
Chantix;Champix
CHEBI:84507
CHEMBL1201135
CHEMBL2062259
CP 526555-18
CP-526,555-18
CP-526555-18
CS-0830
CTK4H8435
D06282
DSSTox_CID_28998
DSSTox_GSID_49072
DSSTox_RID_83263
DTXSID0049072
FT-0675785
HMS3260I15
HY-10021
I14-8434
KB-81430
KS-00000657
LS-186594
MCULE-3291763744
MolPort-006-396-347
MolPort-009-682-971
MolPort-023-220-723
NCGC00260732-01
PubChem18805
PubChem18821
Q-101415
RT-016220
s1440
SB17431
SC-24629
SCHEMBL224851
SCHEMBL224852
SR-00000010464
SR-00000010464-2
Tox21_113630
Tox21_500047
TWYFGYXQSYOKLK-LREBCSMRSA-N
TWYFGYXQSYOKLK-UHFFFAOYSA-N
UNII-82269ASB48
Varenicline (Tartrate)
varenicline monotartrate
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
Varenicline TaTRate
Varenicline(Tartrate)
X1052
X4690
Z1642292115
Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
CHANTIX TABLET;ORAL varenicline tartrate 021928 2010-05-10

US Patents and Regulatory Information for varenicline tartrate

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   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for varenicline tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 91442 Luxembourg   Start Trial 91442, EXPIRES: 20210926
1044189 PA2008010,C1044189 Lithuania   Start Trial PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
1044189 CA 2008 00031 Denmark   Start Trial
1044189 122008000038 Germany   Start Trial 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 SPC021/2008 Ireland   Start Trial SPC021/2008: 20081105, EXPIRES: 20210925
1044189 300355 Netherlands   Start Trial 300355, 20181113, EXPIRES: 20220425
1044189 SPC/GB08/034 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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Boehringer Ingelheim
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.