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Last Updated: April 5, 2020

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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

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Drug patent expirations by year for SELZENTRY
Drug Prices for SELZENTRY

See drug prices for SELZENTRY

Generic Entry Opportunity Date for SELZENTRY
Generic Entry Dates for SELZENTRY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for SELZENTRY*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Burke Rehabilitation HospitalPhase 2/Phase 3
University of California, Los AngelesPhase 2/Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4

See all SELZENTRY clinical trials

Pharmacology for SELZENTRY
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   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
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 022128-004 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

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

Supplementary Protection Certificates for SELZENTRY

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 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 SPC008/2008 Ireland   Start Trial SPC008/2008: 20081105, EXPIRES: 20220917
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 122008000011 Germany   Start Trial 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   Start Trial PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918
1284974 SPC/GB08/014 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Mallinckrodt
McKesson
Medtronic
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.