Details for New Drug Application (NDA): 022128

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NDA 022128 describes SELZENTRY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SELZENTRY profile page.

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

Summary for 022128

Tradename:	SELZENTRY
Applicant:	Viiv Hlthcare
Ingredient:	maraviroc
Patents:	2
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022128

Mechanism of Action	Chemokine Co-receptor 5 Antagonists

Suppliers and Packaging for NDA: 022128

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	ViiV Healthcare Company	49702-223	49702-223-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18)
SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	ViiV Healthcare Company	49702-224	49702-224-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Aug 6, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 6, 2022	Product Flag?		Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	May 25, 2023	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Aug 6, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 6, 2022	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 022128

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	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	022128-001	Aug 6, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.