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Last Updated: September 27, 2023

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

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
Hospital General de México Dr. Eduardo Liceaga	Phase 2

See all maraviroc clinical trials

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

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	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

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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	⤷ 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

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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

International Patents for maraviroc

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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

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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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