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Generated: November 13, 2018

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Details for New Drug Application (NDA): 204671

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NDA 204671 describes SOVALDI, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SOVALDI profile page.

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.
Summary for 204671
Tradename:SOVALDI
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir
Patents:9
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204671
Generic Entry Date for 204671*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 204671
Ingredient-typeNucleoside Analog
Mechanism of ActionRNA Replicase Inhibitors
Medical Subject Heading (MeSH) Categories for 204671
Suppliers and Packaging for NDA: 204671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOVALDI sofosbuvir TABLET;ORAL 204671 NDA Gilead Sciences, Inc. 61958-1501 61958-1501-1 28 TABLET, FILM COATED in 1 BOTTLE (61958-1501-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Dec 6, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 6, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 7, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 7, 2024
Regulatory Exclusivity Use:TREATMENT OF CHRONIC HCV GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN

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