Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Harvard Business School
Moodys
Boehringer Ingelheim
Dow

Last Updated: June 27, 2022

Details for New Drug Application (NDA): 204671


✉ Email this page to a colleague

« Back to Dashboard

NDA 204671 describes SOVALDI, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SOVALDI profile page.

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.
Summary for 204671
Tradename:SOVALDI
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 204671
Mechanism of Action RNA Replicase Inhibitors
Medical Subject Heading (MeSH) Categories for 204671
Suppliers and Packaging for NDA: 204671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOVALDI sofosbuvir TABLET;ORAL 204671 NDA Gilead Sciences, Inc. 61958-1501 61958-1501-1 28 TABLET, FILM COATED in 1 BOTTLE (61958-1501-1)
SOVALDI sofosbuvir TABLET;ORAL 204671 NDA Gilead Sciences, Inc. 61958-1503 61958-1503-1 28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Dec 6, 2013TE:ABRLD: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:Oct 7, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Apr 7, 2024
Regulatory Exclusivity Use:TREATMENT OF CHRONIC HCV GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Express Scripts
McKesson
Harvard Business School
Baxter

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.