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SELZENTRY Drug Profile

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Which patents cover Selzentry, and what generic alternatives are available?

Selzentry is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-eight patent family members in fifty-nine countries.

The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the maraviroc profile page.

Summary for SELZENTRY

International Patents:	248
US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	4
Bulk Api Vendors:	68
Clinical Trials:	18
Patent Applications:	1,948
Formulation / Manufacturing:	see details
DailyMed Link:	SELZENTRY at DailyMed

Generic Entry Opportunity Date for SELZENTRY

NDA:

208984

Dosage::

SOLUTION;ORAL

NDA:

022128

Dosage::

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SELZENTRY

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

Synonyms for SELZENTRY

(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

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 (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

US Patents and Regulatory Information for SELZENTRY

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	022128-002	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	022128-001	Aug 6, 2007		RX	Yes	No			Y	Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007		RX	Yes	Yes			Y	Y

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Paragraph IV (Patent) Challenges for SELZENTRY

Drugname	Dosage	Strength	RLD	Date
	Tablets	150 mg and 300 mg

Non-Orange Book US Patents for SELZENTRY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,503,905	3,3-biarylpiperidine and 2,2-biarylmorpholine derivatives
7,041,667	CCR5 modulators
7,217,714	CCR5 modulators
6,586,431	3,3-Biarylpiperidine and 2,2-biarylmorpholine derivatives

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International Patents for SELZENTRY

Country	Document Number	Estimated Expiration
African Intellectual Property Organization (OAPI)	12264
South Africa	200104255
Canada	2292984
Norway	20025227

Supplementary Protection Certificates for SELZENTRY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
6/2008	Austria		PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES
2008004	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010 20070918
417	Luxembourg		91417, EXPIRES: 20220918