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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 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:	76
Clinical Trials:	131
Patent Applications:	3,604
Formulation / Manufacturing:	see details
DailyMed Link:	maraviroc at DailyMed

Recent Clinical Trials for maraviroc

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rhode Island Hospital	Early Phase 1
Centro de Investigación en. Enfermedades Infecciosas, Mexico	Phase 2
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Phase 2

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET;ORAL
		150MG	TABLET;ORAL
		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

Paragraph IV (Patent) Challenges for MARAVIROC

Tradename	Dosage	Ingredient	NDA	Submissiondate
SELZENTRY	TABLET;ORAL	maraviroc	022128	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	022128-004	Nov 4, 2016		RX	Yes	No					Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007		RX	Yes	Yes					Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016		RX	Yes	No					Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016		RX	Yes	No					Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes					Y

Expired US Patents for maraviroc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016

International Patents for maraviroc

Country	Patent Number	Estimated Expiration
Australia	5248201
Norway	327892
Malaysia	153023
Japan	2003534343
Eurasian Patent Organization	200201141

Supplementary Protection Certificates for maraviroc

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	C300338	Netherlands		PRODUCT NAME: MARAVIROC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	122008000011	Germany		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	08C0007	France		PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918
1284974	C01284974/01	Switzerland		FORMER OWNER: PFIZER INC., US
1284974	91417	Luxembourg		91417, EXPIRES: 20220918