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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. 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

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 25^th, 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.

Summary for SELZENTRY

International Patents:	248
US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	74
Clinical Trials:	19
Patent Applications:	2,435
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SELZENTRY
DailyMed Link:	SELZENTRY at DailyMed

Drug patent expirations by year for SELZENTRY

Generic Entry Opportunity Date for SELZENTRY

Generic Entry Dates for SELZENTRY^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 208984 Dosage: SOLUTION;ORAL
Generic Entry Dates for SELZENTRY^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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,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
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(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

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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	022128-002	Aug 6, 2007		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
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	022128-002	Aug 6, 2007		RX	Yes	Yes	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for SELZENTRY

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

International Patents for SELZENTRY

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Country	Patent Number	Estimated Expiration
Norway	20013237	Start Trial
Georgia, Republic of	P20033131	Start Trial
Japan	2000212159	Start Trial
South Korea	20050046743	Start Trial
Slovakia	287020	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for SELZENTRY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1284974	6/2008	Austria	Start Trial	PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	PA2008004	Lithuania	Start Trial	PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010 20070918
1284974	300338	Netherlands	Start Trial
1284974	CA 2008 00018	Denmark	Start Trial	PRODUCT NAME: MARAVIROC, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description