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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 fourteen 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 NDA: 205834

Tradename:
HARVONI
Applicant:
Gilead Sciences Inc
Ingredient:
ledipasvir; sofosbuvir
Patents:14
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 61958-1801-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG;400MG
Approval Date:Oct 10, 2014TE:RLD:Yes
Patent:8,088,368Patent Expiration:May 12, 2030Product Flag?YSubstance Flag?YDelist Request?
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.


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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