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SELZENTRY Drug Profile

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When do Selzentry patents expire, 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. One supplier is listed for this compound. Additional details are available on the maraviroc profile page.

US ANDA Litigation and Generic Entry Outlook for Selzentry

Selzentry was eligible for patent challenges on August 6, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 25, 2022. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There are two tentative approvals for the generic drug (maraviroc), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SELZENTRY

International Patents:	248
US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	75
Clinical Trials:	19
Patent Applications:	2,435
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SELZENTRY
DailyMed Link:	SELZENTRY at DailyMed

See drug prices for SELZENTRY

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.

Recent Clinical Trials for SELZENTRY

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
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4

See all SELZENTRY clinical trials

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-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,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]cyclohexane-1-carboxamide

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

AKOS025402143

AKOS032960315

API0003256

AS-75265

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)-

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

Maraviroc [INN:BAN:JAN]

Maraviroc [USAN]

Maraviroc, >=98% (HPLC)

Maraviroc(Selzentry)/UK-427857

maravirocum

maravirok

MCULE-2702173987

MD6P741W8A

MFCD13188530

MLS006011960

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

Q421369

Rel-Maraviroc

RT-013662

SB17344

SC-47577

SCHEMBL2177194

SCHEMBL4576508

SCHEMBL51991

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 SELZENTRY

Tradename	Dosage	Ingredient	NDA	Submissiondate
SELZENTRY	TABLET;ORAL	maraviroc	022128	2011-08-08

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
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		RX	Yes	No			Y	Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes				Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016		RX	Yes	No

Expired US Patents for SELZENTRY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016

International Patents for SELZENTRY

Country	Patent Number	Estimated Expiration
Israel	143095
Brazil	9916680
Brazil	PI0110955
Turkey	200200938
Estonia	05170
Serbia	51436
Eurasian Patent Organization	005382

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	08C0007	France		PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918
1284974	6/2008	Austria		PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	SPC008/2008	Ireland		SPC008/2008: 20081105, EXPIRES: 20220917
1284974	C300338	Netherlands		PRODUCT NAME: MARAVIROC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	122008000011	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
1284974	PA 2008 004, C 1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918
1284974	SPC/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