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Last Updated: September 27, 2023

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 and Hetero Labs Ltd Iii, and is included in three NDAs. There is one patent 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. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for maraviroc
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
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
⤷  Try a Trial⤷  Try a Trial300MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial150MGTABLET;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 SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 SOLUTION;ORAL 208984-001 Nov 4, 2016 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-002 Aug 6, 2007 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for maraviroc

Country Patent Number Title Estimated Expiration
Malaysia 156920 TROPANE DERIVATIVES USEFUL IN THERAPY ⤷  Try a Trial
Cuba 23288 DERIVADOS DE TROPANO ÃsTILES EN TERAPIA ⤷  Try a Trial
Czech Republic 299102 Tropanový derivát, zpusoby a meziprodukty pro jeho výrobu, léciva a lécivové kombinace s jeho obsahem (Tropane derivative, methods and intermediates for its preparation, medicaments and therapeutic combinations containing thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for maraviroc

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1284974 91417 Luxembourg ⤷  Try a Trial 91417, EXPIRES: 20220918
1284974 122008000011 Germany ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon
McKesson
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Medtronic

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