Orange Book product · Brand (NDA)
LIVDELZI
SELADELPAR LYSINE
At a glance
Aug 14, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 14, 2024
1 yr 10 mo ago
Today
Patent 7301050 expires
Listed drug substance patent expiration.
Aug 02, 2026
in 1 mo
Patent 7709682 expires
Listed drug substance patent expiration.
Sep 13, 2026
in 3 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 14, 2029
in 3 yr 2 mo
Exclusivity ends · ODE-486
Orphan-drug exclusivity (7 years)
Aug 14, 2031
in 5 yr 3 mo
Patent 10272058 expires
Listed method-of-use patent (U-1854) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 11406611 expires
Listed method-of-use patent (U-1854) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 11596614 expires
Listed method-of-use patent (U-1854) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 9486428 expires
Listed method-of-use patent (U-1854) expiration.
Mar 19, 2035
in 8 yr 11 mo
Pharmaceutical detail
Active ingredient
SELADELPAR LYSINE
Strength
EQ 10MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 217899
Product number
001
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 (2)
- NCENew chemical entity exclusivity (5 years)
Aug 14, 2029
in 3 yr 2 mo
- ODE-486Orphan-drug exclusivity (7 years)
Aug 14, 2031
in 5 yr 3 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7301050 | Aug 02, 2026 | in 1 mo | SubstanceProduct |
| 7709682 | Sep 13, 2026 | in 3 mo | Substance |
| 10272058 | Mar 19, 2035 | in 8 yr 11 mo | U-1854 |
| 11406611 | Mar 19, 2035 | in 8 yr 11 mo | U-1854 |
| 11596614 | Mar 19, 2035 | in 8 yr 11 mo | U-1854 |
| 9486428 | Mar 19, 2035 | in 8 yr 11 mo | U-1854 |
