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Last Updated: January 27, 2023

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 two branded drugs marketed by Viiv Hlthcare and Hetero Labs Ltd Iii, and is included in three NDAs. There are two 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. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for maraviroc
International Patents:96
US Patents:2
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 140
Patent Applications: 6,596
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
National Cancer Institute (NCI)Phase 1/Phase 2
Orlando Immunology CenterPhase 4
Centro de Investigación en. Enfermedades Infecciosas, MexicoPhase 2

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing150MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing300MGTABLET;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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hetero Labs Ltd Iii MARAVIROC maraviroc TABLET;ORAL 203347-002 Feb 7, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc SOLUTION;ORAL 208984-001 Nov 4, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-002 Aug 6, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-001 Aug 6, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-004 Nov 4, 2016 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-001 Aug 6, 2007 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-002 Aug 6, 2007 See Plans and Pricing See Plans and Pricing
>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
Germany 60102233 See Plans and Pricing
Croatia P20020938 TROPANSKI DERIVATI KORISNI U TERAPIJI (TROPANE DERIVATIVES USEFUL IN THERAPY) See Plans and Pricing
Serbia 51436 DERIVATI TRIAZOLIL TROPANA KAO MODULATORI CCR5 (TRIAZOL TROPANE DERIVATIVES AS CCR5 MOUDLATORS) See Plans and Pricing
Taiwan I230160 See Plans and Pricing
Spain 2311126 See Plans and Pricing
Eurasian Patent Organization 005382 ПРОИЗВОДНЫЕ ТРОПАНА, ПОЛЕЗНЫЕ ДЛЯ ТЕРАПИИ (TROPANE DERIVATIVES USEFUL IN THERAPY) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for maraviroc

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1284974 314 Finland See Plans and Pricing
1284974 SPC008/2008 Ireland See Plans and Pricing SPC008/2008: 20081105, EXPIRES: 20220917
1284974 91417 Luxembourg See Plans and Pricing 91417, EXPIRES: 20220918
1284974 122008000011 Germany See Plans and Pricing 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 300338 Netherlands See Plans and Pricing
1284974 PA 2008 004, C 1284974 Lithuania See Plans and Pricing 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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