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Generated: November 18, 2018

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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 varenicline tartrate freedom to operate?

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.

There are eleven drug master file entries for varenicline tartrate. Eight suppliers are listed for this compound.

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
(2S,3S)-2,3-DIHYDROXYBUTANEDIOIC ACID; 5,8,14-TRIAZATETRACYCLO[10.3.1.0(2),(1)(1).0?,?]HEXADECA-2,4(9),5,7,10-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
BC630727
C13H13N3.C4H6O6
CAS-375815-87-5
CCG-221351
Champix
Champix tartrate
Chantix tartrate
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
MFCD08460603
MolPort-006-396-347
MolPort-009-682-971
MolPort-023-220-723
NCGC00260732-01
PL007113
PubChem18805
PubChem18821
Q-101415
RT-016220
s1440
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

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ 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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Supplementary Protection Certificates for varenicline tartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
442 Luxembourg ➤ Sign Up 91442, EXPIRES: 20210926
2008010,C1044189 Lithuania ➤ Sign Up PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
2008 00031 Denmark ➤ Sign Up
1044189/01 Switzerland ➤ Sign Up PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Baxter
Chinese Patent Office
Merck
Johnson and Johnson
Mallinckrodt
Chubb
Medtronic
Cipla

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.