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

International Patents:	249
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	72
Clinical Trials:	128
Patent Applications:	4,048
Formulation / Manufacturing:	see details
DailyMed Link:	maraviroc at DailyMed

Recent Clinical Trials for maraviroc

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

Sponsor	Phase
Burke Rehabilitation Hospital	Phase 2/Phase 3
University of California, Los Angeles	Phase 2/Phase 3
Institut für Klinisch-Onkologische Forschung, Krankenhaus Nordwest GmbH	Phase 1

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	300MG	TABLET;ORAL
Start Trial	Start Trial	150MG	TABLET;ORAL
Start Trial	Start Trial	300MG	TABLET;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

Drug Class	CCR5 Co-receptor Antagonist
Mechanism of Action	Chemokine Co-receptor 5 Antagonists

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

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Glossary

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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

International Patents for maraviroc

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Country	Patent Number	Estimated Expiration
Brazil	9917007	Start Trial
South Korea	100425612	Start Trial
Spain	2215129	Start Trial
Yugoslavia	38801	Start Trial
Hungary	0104910	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for maraviroc

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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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