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Last Updated: May 6, 2021

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Details for New Drug Application (NDA): 212480

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NDA 212480 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 212480
Applicant:Gilead Sciences Inc
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212480
Generic Entry Date for 212480*:
Constraining patent/regulatory exclusivity:

*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.

Pharmacology for NDA: 212480
Mechanism of ActionRNA Replicase Inhibitors
Medical Subject Heading (MeSH) Categories for 212480
Suppliers and Packaging for NDA: 212480
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOVALDI sofosbuvir PELLETS;ORAL 212480 NDA Gilead Sciences, Inc. 61958-1504 61958-1504-1 60 PELLET in 1 PACKET (61958-1504-1)
SOVALDI sofosbuvir PELLETS;ORAL 212480 NDA Gilead Sciences, Inc. 61958-1505 61958-1505-1 80 PELLET in 1 PACKET (61958-1505-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength150MG/PACKET
Approval Date:Aug 28, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 28, 2026
Regulatory Exclusivity Use:
Patent:  Get Started for $10Patent Expiration:Sep 26, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:  Get Started for $10Patent Expiration:Sep 21, 2028Product Flag?Substance Flag?Delist Request?Y

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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 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.