Maraviroc - Generic Drug Details

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

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC

Applicant	Application No.	Strength	Dosage Form
		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	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					Y
Hetero Labs Ltd Iii	MARAVIROC	maraviroc	TABLET;ORAL	203347-002	Feb 7, 2022	AB	RX	No	No
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes					Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007	AB	RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007	AB	RX	Yes	No

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
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007

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

International Patents for maraviroc

Country	Patent Number	Title	Estimated Expiration
Germany	60102233
Croatia	P20020938	TROPANSKI DERIVATI KORISNI U TERAPIJI (TROPANE DERIVATIVES USEFUL IN THERAPY)
Serbia	51436	DERIVATI TRIAZOLIL TROPANA KAO MODULATORI CCR5 (TRIAZOL TROPANE DERIVATIVES AS CCR5 MOUDLATORS)
Taiwan	I230160
Spain	2311126
Eurasian Patent Organization	005382	ПРОИЗВОДНЫЕ ТРОПАНА, ПОЛЕЗНЫЕ ДЛЯ ТЕРАПИИ (TROPANE DERIVATIVES USEFUL IN THERAPY)

Supplementary Protection Certificates for maraviroc

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	314	Finland
1284974	SPC008/2008	Ireland		SPC008/2008: 20081105, EXPIRES: 20220917
1284974	91417	Luxembourg		91417, EXPIRES: 20220918
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	300338	Netherlands
1284974	PA 2008 004, C 1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918