Orange Book product · Brand (NDA)
RYTELO
IMETELSTAT SODIUM
At a glance
Jun 06, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 06, 2024
2 yr 1 mo ago
Today
Patent 9388415 expires
Listed method-of-use patent (U-3956) expiration.
Sep 09, 2026
in 3 mo
Patent 9388416 expires
Listed method-of-use patent (U-3956) expiration.
Sep 09, 2026
in 3 mo
Patent 7494982 expires
Listed drug substance patent expiration.
Dec 27, 2026
in 6 mo
Exclusivity ends · ODE-482
Orphan-drug exclusivity (7 years)
Jun 06, 2031
in 5 yr
Patent 12442000 expires
Listed method-of-use patent (U-3956) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9375485 expires
Listed method-of-use patent (U-3956) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 12171778 expires
Listed method-of-use patent (U-3956) expiration.
Jun 16, 2039
in 13 yr 2 mo
Pharmaceutical detail
Active ingredient
IMETELSTAT SODIUM
Strength
EQ 188MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 217779
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-482Orphan-drug exclusivity (7 years)
Jun 06, 2031
in 5 yr
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9388415 | Sep 09, 2026 | in 3 mo | U-3956 |
| 9388416 | Sep 09, 2026 | in 3 mo | U-3956 |
| 7494982 | Dec 27, 2026 | in 6 mo | SubstanceProduct |
| 12442000 | Mar 15, 2033 | in 6 yr 10 mo | U-3956 |
| 9375485 | Mar 15, 2033 | in 6 yr 10 mo | U-3956 |
| 12171778 | Jun 16, 2039 | in 13 yr 2 mo | U-3956 |
