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 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.
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 204671
| Tradename: | SOVALDI |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | sofosbuvir |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204671
| Mechanism of Action | RNA 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) |
| SOVALDI | sofosbuvir | TABLET;ORAL | 204671 | NDA | Gilead Sciences, Inc. | 61958-1503 | 61958-1503-1 | 28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Dec 6, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Oct 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| 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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