Orange Book product · Brand (NDA)
IWILFIN
EFLORNITHINE HYDROCHLORIDE
At a glance
Dec 13, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2023
2 yr 7 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Dec 13, 2026
in 6 mo
Exclusivity ends · ODE-462
Orphan-drug exclusivity (7 years)
Dec 13, 2030
in 4 yr 7 mo
Patent 12582625 expires
Listed method-of-use patent (U-4444) expiration.
Feb 12, 2036
in 9 yr 10 mo
Pharmaceutical detail
Active ingredient
EFLORNITHINE HYDROCHLORIDE
Strength
EQ 192MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215500
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)
- NPNew product exclusivity (3 years)
Dec 13, 2026
in 6 mo
- ODE-462Orphan-drug exclusivity (7 years)
Dec 13, 2030
in 4 yr 7 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12582625 | Feb 12, 2036 | in 9 yr 10 mo | U-4444 |
