Orange Book product · Brand (NDA)
IQIRVO
ELAFIBRANOR
At a glance
Jun 10, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 10, 2024
2 yr 1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 10, 2029
in 3 yr
Exclusivity ends · ODE-486
Orphan-drug exclusivity (7 years)
Jun 10, 2031
in 5 yr 1 mo
Patent 11185519 expires
Listed method-of-use patent (U-3955) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 11331292 expires
Listed method-of-use patent (U-1854) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 11850223 expires
Listed method-of-use patent (U-1854) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 11857523 expires
Listed method-of-use patent (U-3955) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 12233038 expires
Listed method-of-use patent (U-1854) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 12295927 expires
Listed method-of-use patent (U-1854) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 12295928 expires
Listed method-of-use patent (U-1854) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 12310935 expires
Listed method-of-use patent (U-1854) expiration.
Mar 30, 2037
in 10 yr 11 mo
Patent 12589086 expires
Listed method-of-use patent (U-4473) expiration.
Mar 30, 2037
in 10 yr 11 mo
Pharmaceutical detail
Active ingredient
ELAFIBRANOR
Strength
80MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218860
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)
Jun 10, 2029
in 3 yr
- ODE-486Orphan-drug exclusivity (7 years)
Jun 10, 2031
in 5 yr 1 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11185519 | Mar 30, 2037 | in 10 yr 11 mo | U-3955 |
| 11331292 | Mar 30, 2037 | in 10 yr 11 mo | U-1854 |
| 11850223 | Mar 30, 2037 | in 10 yr 11 mo | U-1854 |
| 11857523 | Mar 30, 2037 | in 10 yr 11 mo | U-3955 |
| 12233038 | Mar 30, 2037 | in 10 yr 11 mo | U-1854 |
| 12295927 | Mar 30, 2037 | in 10 yr 11 mo | U-1854 |
| 12295928 | Mar 30, 2037 | in 10 yr 11 mo | U-1854 |
| 12310935 | Mar 30, 2037 | in 10 yr 11 mo | U-1854 |
| 12589086 | Mar 30, 2037 | in 10 yr 11 mo | U-4473 |

