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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Cantor Fitzgerald
US Army
Harvard Business School
Johnson and Johnson

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204671

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

The generic ingredient in SOVALDI is sofosbuvir. There are six 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
Applicant:Gilead Sciences Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 204671
Ingredient-typeNucleoside Analog
Mechanism of ActionRNA 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Dec 6, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 6, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 7, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 7, 2024
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Queensland Health
US Department of Justice

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