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Last Updated: July 23, 2021

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Details for New Drug Application (NDA): 208984

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NDA 208984 describes SELZENTRY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. There are three 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. One supplier is listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 208984
Applicant:Viiv Hlthcare
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208984
Generic Entry Date for 208984*:
Constraining patent/regulatory exclusivity:

*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.

Pharmacology for NDA: 208984
Suppliers and Packaging for NDA: 208984
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SELZENTRY maraviroc SOLUTION;ORAL 208984 NDA ViiV Healthcare Company 49702-237 49702-237-55 1 BOTTLE in 1 CARTON (49702-237-55) > 230 mL in 1 BOTTLE
SELZENTRY maraviroc SOLUTION;ORAL 208984 NDA ViiV Healthcare Company 49702-260 49702-260-55 1 KIT in 1 CARTON (49702-260-55) * 230 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Nov 4, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 30, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 30, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Try it FreePatent Expiration:Feb 6, 2022Product Flag?Substance Flag?Delist Request?Y

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