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Last Updated: December 6, 2021

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MARAVIROC - Generic Drug Details

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What are the generic drug sources for maraviroc and what is the scope of freedom to operate?

Maraviroc is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Maraviroc has ninety-six patent family members in fifty-five countries.

There are two drug master file entries for maraviroc. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for MARAVIROC
International Patents:96
US Patents:3
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 138
Patent Applications: 6,838
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in MARAVIROC?MARAVIROC excipients list
DailyMed Link:MARAVIROC at DailyMed
Recent Clinical Trials for MARAVIROC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2
Centro de Investigación en. Enfermedades Infecciosas, MexicoPhase 2
Hospital General de México Dr. Eduardo LiceagaPhase 2

See all MARAVIROC clinical trials

Generic filers with tentative approvals for MARAVIROC
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial300MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial150MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial300MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MARAVIROC
Paragraph IV (Patent) Challenges for MARAVIROC
Tradename Dosage Ingredient NDA Submissiondate
SELZENTRY TABLET;ORAL maraviroc 022128 2011-08-08

US Patents and Regulatory Information for MARAVIROC

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 MARAVIROC

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

Supplementary Protection Certificates for MARAVIROC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1284974 300338 Netherlands ⤷  Free Forever Trial
1284974 PA2008004 Lithuania ⤷  Free Forever Trial PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010 20070918
1284974 SZ 6/2008 Austria ⤷  Free Forever Trial PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Dow
Johnson and Johnson
Harvard Business School
Mallinckrodt

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