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Cerilliant
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Boehringer Ingelheim
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Harvard Business School
QuintilesIMS
Cipla
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Generated: April 23, 2018

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 one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the HARVONI profile page.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. One supplier is 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:15
Formulation / Manufacturing:see details
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 N 61958-1801-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG;400MG
Approval Date:Oct 10, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 12, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE SUBJECTS INFECTED WITH CHRONIC HEPATITIS C, GENOTYPE 6 VIRUS INFECTION BASED UPON THE RESULTS OF THE ELECTRON- 2 STUDY
Regulatory Exclusivity Expiration:Nov 12, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE THE TREATMENT OF SUBJECTS WITH GENOTYPE 5 CHRONIC HEPATITIS C VIRUS INFECTION BASED ON THE RESULTS FROM STUDY GS-US-337-119.
Regulatory Exclusivity Expiration:Nov 12, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE TREATMENT OF GENOTYPE 4, CHRONIC HEPATITIS C VIRUS INFECTION BASED UPON THE RESULTS FROM STUDIES ION-4 AND GS-US-337-119.

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Chubb
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