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Maraviroc - Generic Drug Details
What are the generic sources for maraviroc and what is the scope of patent protection?
Maraviroc
is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in two NDAs. There are three 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. One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for maraviroc
| International Patents: | 96 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 128 |
| Patent Applications: | 4,166 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | maraviroc at DailyMed |
Recent Clinical Trials for maraviroc
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Burke Rehabilitation Hospital | Phase 2/Phase 3 |
| University of California, Los Angeles | Phase 2/Phase 3 |
| University Hospital Heidelberg | Phase 1 |
Generic filers with tentative approvals for MARAVIROC
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 300MG | TABLET;ORAL |
| Start Trial | Start Trial | 150MG | TABLET;ORAL |
| Start Trial | Start Trial | 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
| 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 | 022128-002 | Aug 6, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-004 | Nov 4, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-002 | Aug 6, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-001 | Aug 6, 2007 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-001 | Aug 6, 2007 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-001 | Aug 6, 2007 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-004 | Nov 4, 2016 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-002 | Aug 6, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for maraviroc
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100523501 | Start Trial |
| Ukraine | 73170 | Start Trial |
| Hong Kong | 1078573 | Start Trial |
| Malaysia | 153023 | Start Trial |
| Austria | 260914 | Start Trial |
| Serbia | 51436 | Start Trial |
| Slovakia | 16432002 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for maraviroc
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1284974 | 6/2008 | Austria | Start Trial | PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918 |
| 1284974 | 300338 | Netherlands | Start Trial | |
| 1284974 | 08C0007 | France | Start Trial | PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918 |
| 1284974 | 122008000011 | Germany | Start 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 | SPC/GB08/014 | United Kingdom | Start Trial | PRODUCT NAME: MARAVIROC, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/07/418/001 20070918; UK EU/1/04/418/002 20070918; UK EU/1/04/418/003 20070918; UK EU/1/04/418/004 20070918; UK EU/1/04/418/005 20070918; UK EU/1/04/418/006 20070918; UK EU/1/04/418/007 20070918; UK EU/1/04/418/008 20070918; UK EU/1/04/418/009 20070918; UK EU/1/04/418/010 20070918 |
| 1284974 | SZ 6/2008 | Austria | Start Trial | PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES |
| 1284974 | PA2008004,C1284974 | Lithuania | Start Trial | PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 0070918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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