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Last Updated: August 14, 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 three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-six patent family members in fifty-five 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
Hospital Universitario Infanta LeonorPhase 2
Hospital Clínic de BarcelonaPhase 2
ViiV HealthcarePhase 2

See all SELZENTRY clinical trials

Pharmacology for SELZENTRY
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 SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-004 Nov 4, 2016 RX Yes No   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   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-001 Aug 6, 2007 RX Yes No   Start Trial   Start Trial 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

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 022128-002 Aug 6, 2007   Start Trial   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 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 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 PA2008004,C1284974 Lithuania   Start Trial PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 0070918
1284974 91417 Luxembourg   Start Trial 91417, EXPIRES: 20220918
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:

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Medtronic
Express Scripts

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