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Generated: December 12, 2018

DrugPatentWatch Database Preview

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 three suppliers. There are four 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 208984
Tradename:SELZENTRY
Applicant:Viiv Hlthcare
Ingredient:maraviroc
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208984
Generic Entry Date for 208984*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.

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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Nov 4, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 4, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Dec 1, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
Patent:➤ Sign UpPatent Expiration:Aug 6, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1

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