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
International Patents: | 96 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 140 |
Patent Applications: | 6,922 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for maraviroc |
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 |
Hospital General de México Dr. Eduardo Liceaga | Phase 2 |
Generic filers with tentative approvals for MARAVIROC
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 300MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 150MG | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for maraviroc
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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