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Last Updated: July 18, 2024

Maraviroc - Generic Drug Details


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What are the generic sources for maraviroc and what is the scope of patent protection?

Maraviroc is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Hetero Labs Ltd Iii, and I 3 Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for maraviroc. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for maraviroc

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Recent Clinical Trials for maraviroc

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

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
Orlando Immunology CenterPhase 4
CCINSHAE. Secretaría de Salud. MéxicoPhase 2

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up300MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up150MGTABLET;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 Strength NDA ANDAs Submitted Submissiondate
SELZENTRY Tablets maraviroc 150 mg and 300 mg 022128 2 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 022128-001 Aug 6, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii MARAVIROC maraviroc TABLET;ORAL 203347-002 Feb 7, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-004 Nov 4, 2016 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 022128-001 Aug 6, 2007 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-002 Aug 6, 2007 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for maraviroc

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
ViiV Healthcare B.V. Celsentri maraviroc EMEA/H/C/000811
Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable,
Authorised no no no 2007-09-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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