Orange Book product · Brand (NDA)
SOVALDI
SOFOSBUVIR
At a glance
Aug 28, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 28, 2019
6 yr 11 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Aug 28, 2026
in 2 mo
Patent 8334270 expires
Listed drug substance patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8580765 expires
Listed drug substance patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 9085573 expires
Listed drug substance patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8334270*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 8580765*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 9085573*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 7964580 expires
Listed drug substance patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8633309 expires
Listed drug substance patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8889159 expires
Listed drug product patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 7964580*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8633309*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8889159*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 9284342 expires
Listed drug substance patent expiration.
Sep 13, 2030
in 4 yr 4 mo
Patent 8618076 expires
Listed drug substance patent expiration.
Dec 11, 2030
in 4 yr 7 mo
Patent 9284342*PED expires
Listed listed patent expiration.
Mar 13, 2031
in 4 yr 10 mo
Patent 8618076*PED expires
Listed listed patent expiration.
Jun 11, 2031
in 5 yr 1 mo
Pharmaceutical detail
Active ingredient
SOFOSBUVIR
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 204671
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- ODE*FDA marketing exclusivity
Aug 28, 2026
in 2 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8334270 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 8580765 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 9085573 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 8334270*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8580765*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 9085573*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 7964580 | Mar 26, 2029 | in 2 yr 10 mo | SubstanceProductU-1470 |
| 8633309 | Mar 26, 2029 | in 2 yr 10 mo | SubstanceProductU-1470 |
| 8889159 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1470 |
| 7964580*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8633309*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8889159*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 9284342 | Sep 13, 2030 | in 4 yr 4 mo | SubstanceProductU-1470 |
| 8618076 | Dec 11, 2030 | in 4 yr 7 mo | SubstanceProductU-1470 |
| 9284342*PED | Mar 13, 2031 | in 4 yr 10 mo | |
| 8618076*PED | Jun 11, 2031 | in 5 yr 1 mo |
