SELZENTRY Drug Patent Profile

Which patents cover Selzentry, and what generic alternatives are available?

Selzentry is a drug marketed by Viiv Hlthcare and is included in two NDAs.

The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the maraviroc profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Selzentry

A generic version of SELZENTRY was approved as maraviroc by HETERO LABS LTD III on February 7^th, 2022.

Summary for SELZENTRY

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	43
Patent Applications:	5,576
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SELZENTRY
What excipients (inactive ingredients) are in SELZENTRY?	SELZENTRY excipients list
DailyMed Link:	SELZENTRY at DailyMed

See drug prices for SELZENTRY

Recent Clinical Trials for SELZENTRY

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

Sponsor	Phase
Hospital Clínic de Barcelona	Phase 2
Hospital Universitario Infanta Leonor	Phase 2
Hospital Clinic of Barcelona	Phase 2

See all SELZENTRY clinical trials

Pharmacology for SELZENTRY

Drug Class	CCR5 Co-receptor Antagonist
Mechanism of Action	Chemokine Co-receptor 5 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SELZENTRY

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

Paragraph IV (Patent) Challenges for SELZENTRY

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 SELZENTRY

SELZENTRY is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting SELZENTRY

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
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016		DISCN	Yes	No
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		DISCN	Yes	No

Expired US Patents for SELZENTRY

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	TABLET;ORAL	022128-004	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016

EU/EMA Drug Approvals for SELZENTRY

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 SELZENTRY

See the table below for patents covering SELZENTRY around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	5248201
Australia	763644
Peru	13712000
Estonia	200100347

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	SZ 6/2008	Austria		PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES
1284974	PA2008004,C1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 0070918
1284974	314	Finland
1284974	CA 2008 00018	Denmark		PRODUCT NAME: MARAVIROC, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT