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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.
Generic Entry Opportunity Date for 204671
*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: 204671
Medical Subject Heading (MeSH) Categories for 204671
Profile for product number 001
|Approval Date:||Dec 6, 2013||TE:||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:||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|
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