Details for New Drug Application (NDA): 204671
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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.
Summary for 204671
| Tradename: | SOVALDI |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | sofosbuvir |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204671
Generic Entry Date for 204671*:
Constraining patent/regulatory exclusivity:
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) Dosage:
TABLET;ORAL |
*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
| 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) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 26, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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