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Last Updated: May 25, 2022

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 one supplier. 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. Two 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
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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 6, 2007TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 6, 2022Product Flag?Substance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:May 25, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Aug 6, 2007TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 6, 2022Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 022128

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-002 Aug 6, 2007 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-004 Nov 4, 2016 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-001 Aug 6, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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