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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 eight patents protecting this drug. Additional details are available on the SOVALDI profile page.

The generic ingredient in SOVALDI is sofosbuvir. There are two 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 NDA: 204671

Tradename:
SOVALDI
Applicant:
Gilead Sciences Inc
Ingredient:
sofosbuvir
Patents:8
Formulation / Manufacturing:see details

Pharmacology for NDA: 204671

Ingredient-typeNucleoside Analog
Mechanism of ActionRNA Replicase Inhibitors

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Dec 6, 2013TE:RLD:Yes
Patent:7,964,580Patent Expiration:Mar 26, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:FOR THE TREATMENT OF HEPATITIS C
Patent:8,334,270Patent Expiration:Mar 21, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:FOR THE TREATMENT OF HEPATITIS C
Patent:8,580,765Patent Expiration:Mar 21, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:FOR THE TREATMENT OF HEPATITIS C


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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 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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