Orange Book product · Brand (NDA)
AURLUMYN
ILOPROST
At a glance
Feb 13, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2024
2 yr 5 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 13, 2027
in 8 mo
Exclusivity ends · ODE-465
Orphan-drug exclusivity (7 years)
Feb 13, 2031
in 4 yr 9 mo
Patent 12409184 expires
Listed drug product patent expiration.
Aug 06, 2041
in 15 yr 4 mo
Patent 12409183 expires
Listed method-of-use patent (U-4263) expiration.
Jul 18, 2044
in 18 yr 4 mo
Pharmaceutical detail
Active ingredient
ILOPROST
Strength
100MCG/ML (100MCG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 217933
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)
Feb 13, 2027
in 8 mo
- ODE-465Orphan-drug exclusivity (7 years)
Feb 13, 2031
in 4 yr 9 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12409184 | Aug 06, 2041 | in 15 yr 4 mo | Product |
| 12409183 | Jul 18, 2044 | in 18 yr 4 mo | U-4263 |
