Orange Book product · Brand (NDA)
INLURIYO
IMLUNESTRANT TOSYLATE
At a glance
Sep 25, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2025
9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 25, 2030
in 4 yr 4 mo
Patent 10654866 expires
Listed drug substance patent expiration.
Jul 11, 2039
in 13 yr 3 mo
Patent 11117902 expires
Listed drug substance patent expiration.
Jul 11, 2039
in 13 yr 3 mo
Pharmaceutical detail
Active ingredient
IMLUNESTRANT TOSYLATE
Strength
EQ 200MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218881
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 (1)
- NCENew chemical entity exclusivity (5 years)
Sep 25, 2030
in 4 yr 4 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10654866 | Jul 11, 2039 | in 13 yr 3 mo | SubstanceProductU-4278 |
| 11117902 | Jul 11, 2039 | in 13 yr 3 mo | SubstanceProductU-4278 |
