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Last Updated: June 28, 2022

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 one supplier. There are seventeen 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. 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:17
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205834
Generic Entry Date for 205834*:
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.

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:Aug 28, 2026
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Regulatory Exclusivity Expiration:Nov 15, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
Regulatory Exclusivity Expiration:Oct 7, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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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 verification 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.