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SELZENTRY Drug Profile

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When do Selzentry patents expire, and what generic alternatives are available?

Selzentry is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-six patent family members in fifty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Selzentry

Selzentry was eligible for patent challenges on August 6, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 25, 2023. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There are two tentative approvals for the generic drug (maraviroc), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SELZENTRY

International Patents:	96
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	5,044
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for SELZENTRY

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

208984

Dosage:

SOLUTION;ORAL

NDA:

022128

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SELZENTRY

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

Sponsor	Phase
ViiV Healthcare	Phase 2
Hospital Universitario Infanta Leonor	Phase 2
Hospital Clínic de 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

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	NDA	Submissiondate
SELZENTRY	TABLET;ORAL	maraviroc	022128	2011-08-08

US Patents and Regulatory Information for 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					Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		RX	Yes	No					Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007		RX	Yes	No					Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		RX	Yes	No					Y
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007		RX	Yes	Yes					Y

Expired US Patents for SELZENTRY

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

International Patents for SELZENTRY

Country	Patent Number	Estimated Expiration
Portugal	1140085
European Patent Office	1990341
Guatemala	199900219
Slovakia	16432002
Panama	8517101
Eurasian Patent Organization	007580

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	6/2008	Austria		PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	300338	Netherlands
1284974	SPC/GB08/014	United Kingdom		PRODUCT NAME: MARAVIROC, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/07/418/001 20070918; UK EU/1/04/418/002 20070918; UK EU/1/04/418/003 20070918; UK EU/1/04/418/004 20070918; UK EU/1/04/418/005 20070918; UK EU/1/04/418/006 20070918; UK EU/1/04/418/007 20070918; UK EU/1/04/418/008 20070918; UK EU/1/04/418/009 20070918; UK EU/1/04/418/010 20070918
1284974	314	Finland
1284974	08C0007	France		PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918