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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212477


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NDA 212477 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 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. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
Summary for 212477
Tradename:HARVONI
Applicant:Gilead Sciences Inc
Ingredient:ledipasvir; sofosbuvir
Patents:16
Generic Entry Opportunity Date for 212477
Generic Entry Date for 212477*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;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: 212477
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477 NDA Gilead Sciences, Inc 61958-1804 61958-1804-1 120 PELLET in 1 PACKET (61958-1804-1)
HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477 NDA Gilead Sciences, Inc 61958-1805 61958-1805-1 90 PELLET in 1 PACKET (61958-1805-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength33.75MG;150MG/PACKET
Approval Date:Aug 28, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 15, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE DOSIG 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:Aug 28, 2026
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
Regulatory Exclusivity Expiration:Aug 28, 2026
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

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