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Last Updated: November 21, 2019

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Maraviroc - Generic Drug Details

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What are the generic sources for maraviroc and what is the scope of patent protection?

Maraviroc is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in two NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Maraviroc has two hundred and forty-nine patent family members in fifty-nine countries.

There are two drug master file entries for maraviroc. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for maraviroc
Recent Clinical Trials for maraviroc

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

SponsorPhase
Burke Rehabilitation HospitalPhase 2/Phase 3
University of California, Los AngelesPhase 2/Phase 3
Institut für Klinisch-Onkologische Forschung, Krankenhaus Nordwest GmbHPhase 1

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial300MGTABLET;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 maraviroc
Synonyms for maraviroc
(non-labelled)Maraviroc-d6
[3H]maraviroc
[3H]UK 427,857
[3H]UK-427,857
348M651
376348-65-1
4,4-Difluoro-cyclohexanecarboxylic acid {(S)-3-[(1S,5S)-3-(3-isopropyl-5-methyl-[1,2,4]triazol-4-yl)-8-aza-bicyclo[3.2.1]oct-8-yl]-1-phenyl-propyl}-amide
4,4-difluoro-N-((1S)-3-((1R,5S)-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]octan-8-yl)-1-phenylpropyl)cyclohexane-1-carboxamide
4,4-difluoro-N-((1S)-3-((1R,5S)-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]octan-8-yl)-1-phenylpropyl)cyclohexanecarboxamide
4,4-difluoro-N-((1S)-3-(3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]octan-8-yl)-1-phenylpropyl)cyclohexanecarboxamide
4,4-difluoro-N-((S)-3-((1S,3R,5R)-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-aza-bicyclo[3.2.1]octan-8-yl)-1-phenylpropyl)cyclohexanecarboxamide
4,4-difluoro-N-((S)-3-((1S,3S,5R)-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-aza-bicyclo[3.2.1]octan-8-yl)-1-phenylpropyl)cyclohexanecarboxamide
4,4-difluoro-N-[(1S)-3-[(1R,5S)-3-(3-isopropyl-5-methyl-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]octan-8-yl]-1-phenyl-propyl]cyclohexanecarboxamide
4,4-difluoro-N-[(1S)-3-[(1R,5S)-3-(3-methyl-5-propan-2-yl-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]octan-8-yl]-1-phenylpropyl]cyclohexane-1-carboxamide
4,4-difluoro-N-[(1S)-3-[(1R,5S)-3-[3-methyl-5-(propan-2-yl)-4H-1,2,4-triazol-4-yl]-8-azabicyclo[3.2.1]octan-8-yl]-1-phenylpropyl]cyclohexane-1-carboxamide
4,4-difluoro-N-[(1S)-3-[(1S,5R)-3-(3-isopropyl-5-methyl-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]octan-8-yl]-1-phenyl-propyl]cyclohexanecarboxamide
4,4-DIFLUORO-N-[(1S)-3-[(1S,5R)-3-(3-METHYL-5-PROPAN-2-YL-1,2,4-TRIAZO L-4-YL)-8-AZABICYCLO[3.2.1]OCT-8-YL]-1-PHENYL-PROPYL]CYCLOHEXANE-1-CAR BOXAMIDE
4,4-Difluoro-N-[(1S)-3-[(3-exo)-3-[3-methyl-5-(1-methylethyl)-4H-1,2,4-triazol-4-yl]-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl]cyclohexanecarboxamide
4,4-Difluoro-N-[(1s)-3-{(3-Exo)-3-[3-Methyl-5-(Propan-2-Yl)-4h-1,2,4-Triazol-4-Yl]-8-Azabicyclo[3.2.1]oct-8-Yl}-1-Phenylpropyl]cyclohexanecarboxamide
4,4-difluoro-N-{(1S)-3-[(3-exo)-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide
674782-29-7
ABP000248
AC-558
AC1MHEFQ
AK687992
AKOS025402143
AKOS032946723
AKOS032960315
API0003256
BC297754
BDBM50334986
BRD-A23284911-001-02-4
C29H41F2N5O
Celsentri
Celsentri(TM)
CHEBI:63608
CHEMBL1201187
CHEMBL256907
CHEMBL584744
CS-0366
CTK5C6225
Cyclohexanecarboxamide, 4,4-difluoro-N-((1S)-3-((3-exo)-3-(3-methyl-5-(1-methylethyl)-4H-1,2,4-triazol-4-yl)-8-azabicyclo(3.2.1)oct-8-yl)-1-phenylpropyl)-
DB04835
EX-A200
exo-4,4-Difluoro-N-[3-[3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1(S)-phenylpropyl]cyclohexanecarboxamide
FT-0654501
GSNHKUDZZFZSJB-QYOOZWMWSA-N
GTPL803
GTPL806
HSDB 8021
HY-13004
Isopropyl, 4,4-difluoro-N-((1S)-3-{(1R,3s,5S)-3-(3-methyl-5-(propan-2-yl)-4H-1,2,4-triazol-4-yl)-8-azabicyclo(3.2.1)octan-8-yl}-1-phenylpropyl)cyclohexanecarboxamide
J-521678
LS-182818
Maraviroc [INN:BAN:JAN]
Maraviroc [USAN]
Maraviroc, >=98% (HPLC)
Maraviroc(Selzentry)/UK-427857
Maraviroc|376348-65-1|Selzentry|Celsentri
maravirocum
MCULE-2702173987
MD6P741W8A
MFCD13188530
MLS006011960
MolPort-020-005-896
MolPort-044-728-878
MRV
MVC
NCGC00183109-01
NCGC00183109-02
PRO 140 (Anti-CCR5 monoclonal antibody) & exo-4,4-Difluoro-N-[3-[3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1(S)-phenylpropyl]cyclohexanecarboxamide
PRO 140 & Maraviroc
PubChem18277
Rel-Maraviroc
RL03435
RT-013662
SB17344
SC-47577
SCHEMBL2177194
SCHEMBL4576508
SCHEMBL51991
Selzentry
Selzentry(TM)
SMR004703532
SR-01000942244
SR-01000942244-1
UK 427857
UK-427,857
UK-427,857 maraviroc (MVC)
UK-427857
UNII-MD6P741W8A
X5004
Z1618161028
ZINC100003902
ZINC101160855
ZINC3817234
Paragraph IV (Patent) Challenges for MARAVIROC
Tradename Dosage Ingredient NDA Submissiondate
SELZENTRY TABLET;ORAL maraviroc 022128 2011-08-08

US Patents and Regulatory Information for maraviroc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-001 Aug 6, 2007 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-004 Nov 4, 2016 RX Yes No   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 maraviroc

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1284974 08C0007 France   Start Trial PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918
1284974 CA 2008 00018 Denmark   Start Trial PRODUCT NAME: MARAVIROC, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT
1284974 C300338 Netherlands   Start Trial PRODUCT NAME: MARAVIROC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974 PA2008004,C1284974 Lithuania   Start Trial PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 0070918
1284974 PA 2008 004, C 1284974 Lithuania   Start Trial PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
McKinsey
McKesson
Moodys
Merck

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