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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Cantor Fitzgerald
Julphar
Healthtrust
Accenture
AstraZeneca
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
Tradename:SOVALDI
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir
Patents:9
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:

Julphar
QuintilesIMS
Cantor Fitzgerald
Cerilliant
Harvard Business School
Queensland Health
Teva
US Department of Justice
Citi

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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