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-258
Orphan-drug exclusivity (7 years)
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/PACKET
Dosage form
PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 212480
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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-258Orphan-drug exclusivity (7 years)
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 |
