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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205834

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NDA 205834 describes HARVONI, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from two suppliers. There are sixteen patents protecting this drug. Additional details are available on the HARVONI profile page.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
Summary for 205834
Tradename:HARVONI
Applicant:Gilead Sciences Inc
Ingredient:ledipasvir; sofosbuvir
Patents:16
Generic Entry Opportunity Date for 205834
Generic Entry Date for 205834*:
Constraining patent/regulatory exclusivity:
PEDIATRIC 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.

Suppliers and Packaging for NDA: 205834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834 NDA Gilead Sciences, Inc 61958-1801 61958-1801-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1)
HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834 NDA Gilead Sciences, Inc 61958-1803 61958-1803-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG;400MG
Approval Date:Oct 10, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 10, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 7, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Oct 7, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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