Orange Book product · Brand (NDA)
LYNAVOY
LINERIXIBAT
At a glance
Mar 17, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2026
3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 17, 2031
in 4 yr 10 mo
Patent 9040518 expires
Listed drug substance patent expiration.
Sep 06, 2031
in 5 yr 4 mo
Exclusivity ends · ODE-517
Orphan-drug exclusivity (7 years)
Mar 17, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
LINERIXIBAT
Strength
40MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 220295
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)
Mar 17, 2031
in 4 yr 10 mo
- ODE-517Orphan-drug exclusivity (7 years)
Mar 17, 2033
in 6 yr 10 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9040518 | Sep 06, 2031 | in 5 yr 4 mo | SubstanceProduct |

