Orange Book product · Brand (NDA)
ZOKINVY
LONAFARNIB
Brand (NDA)NDA 213969RX SENTYNL THERAPS INC
At a glance
Nov 20, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2020
5 yr 8 mo ago
Today
Exclusivity ends · ODE-324
Orphan-drug exclusivity (7 years)
Nov 20, 2027
in 1 yr 5 mo
Patent 7838531 expires
Listed method-of-use patent (U-3070) expiration.
Jul 26, 2029
in 3 yr 2 mo
Pharmaceutical detail
Active ingredient
LONAFARNIB
Strength
75MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 213969
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-324Orphan-drug exclusivity (7 years)
Nov 20, 2027
in 1 yr 5 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7838531 | Jul 26, 2029 | in 3 yr 2 mo | U-3070 |
