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Maraviroc - Generic Drug Details

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What are the generic drug sources for maraviroc and what is the scope of maraviroc freedom to operate?

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-eight patent family members in fifty-nine countries.

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

Summary for maraviroc

International Patents:	248
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	69
Clinical Trials:	128
Patent Applications:	3,464
Formulation / Manufacturing:	see details
DailyMed Link:	maraviroc at DailyMed

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-?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-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-((1S)-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

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

AKOS025402143

AKOS032946723

API0003256

BC297754

BDBM50334986

BRD-A23284911-001-02-4

C29H41F2N5O

Celsentri

Celsentri (TN)

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]-

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)-

D0NR6S

D0T8DO

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

HE070818

HE116184

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 [USAN]

Maraviroc, >=98% (HPLC)

Maraviroc(Selzentry)/UK-427857

Maraviroc|376348-65-1|Selzentry|Celsentri

maravirocum

maravirok

marawirok

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

SC-47577

SCHEMBL2177194

SCHEMBL4576508

SCHEMBL51991

Selzentry

Selzentry (TN)

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

Tentative approvals for MARAVIROC

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

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
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes			Y	Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		RX	Yes	No

International Patents for maraviroc

Country	Document Number	Estimated Expiration
Hungary	0302474
Norway	2010007
Brazil	9917007
Japan	3779111
South Africa	200104254

Supplementary Protection Certificates for maraviroc

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2008 00018	Denmark		PRODUCT NAME: MARAVIROC, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT
C/GB08/014	United Kingdom		PRODUCT NAME: MARAVIROC, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/07/418/001 20070918; UK EU/1/04/418/002 20070918; UK EU/1/04/418/003 20070918; UK EU/1/04/418/004 20070918; UK EU/1/04/418/005 20070918; UK EU/1/04/418/006 20070918; UK EU/1/04/418/007 20070918; UK EU/1/04/418/008 20070918; UK EU/1/04/418/009 20070918; UK EU/1/04/418/010 20070918
2008 004, C 1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918
2008000011	Germany		PRODUCT NAME: 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; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
C0007	France		PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918