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
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Orlando Immunology Center | Phase 4 |
Centro de Investigación en. Enfermedades Infecciosas, Mexico | Phase 2 |
Generic filers with tentative approvals for MARAVIROC
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 150MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 300MG | TABLET;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
Drug Class | CCR5 Co-receptor Antagonist |
Mechanism of Action | Chemokine Co-receptor 5 Antagonists |
US Patents and Regulatory Information for maraviroc
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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