Orange Book product · Brand (NDA)
OLYSIO
SIMEPREVIR SODIUM
At a glance
Nov 22, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2013
12 yr 9 mo ago
Today
Patent 8349869 expires
Listed drug substance patent expiration.
Jul 28, 2026
in 1 mo
Patent 8741926 expires
Listed drug substance patent expiration.
Jul 28, 2026
in 1 mo
Patent 8754106 expires
Listed drug substance patent expiration.
Jul 28, 2026
in 1 mo
Patent 9040562 expires
Listed drug substance patent expiration.
Jul 28, 2026
in 1 mo
Patent 9353103 expires
Listed method-of-use patent (U-1467) expiration.
Jul 28, 2026
in 1 mo
Patent 9623022 expires
Listed method-of-use patent (U-1467) expiration.
Jul 28, 2026
in 1 mo
Patent 9856265 expires
Listed drug substance patent expiration.
Jul 28, 2026
in 1 mo
Patent 8148399 expires
Listed drug substance patent expiration.
Sep 05, 2029
in 3 yr 3 mo
Pharmaceutical detail
Active ingredient
SIMEPREVIR SODIUM
Strength
EQ 150MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 205123
Product number
001
Marketing status
DISCN
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.
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8349869 | Jul 28, 2026 | in 1 mo | SubstanceProductU-1467 |
| 8741926 | Jul 28, 2026 | in 1 mo | SubstanceU-1467 |
| 8754106 | Jul 28, 2026 | in 1 mo | SubstanceU-1467 |
| 9040562 | Jul 28, 2026 | in 1 mo | SubstanceProductU-1467 |
| 9353103 | Jul 28, 2026 | in 1 mo | U-1467 |
| 9623022 | Jul 28, 2026 | in 1 mo | U-1467 |
| 9856265 | Jul 28, 2026 | in 1 mo | SubstanceProductU-1467 |
| 8148399 | Sep 05, 2029 | in 3 yr 3 mo | SubstanceProductU-1467 |
