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, Hetero Labs Ltd Iii, and I 3 Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for maraviroc. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for maraviroc

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	140
Patent Applications:	6,222
Drug Prices:	Drug price trends for maraviroc
What excipients (inactive ingredients) are in maraviroc?	maraviroc excipients list
DailyMed Link:	maraviroc at DailyMed

See drug prices for maraviroc

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
⤷ Sign Up	⤷ Sign Up	300MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
I 3 Pharms	MARAVIROC	maraviroc	TABLET;ORAL	217114-002	Aug 17, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

EU/EMA Drug Approvals for maraviroc

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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

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