Orange Book product · Brand (NDA)
FOUNDAYO
ORFORGLIPRON CALCIUM
At a glance
Apr 01, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 01, 2026
3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
Patent RE50455 expires
Listed drug substance patent expiration.
Sep 26, 2037
in 11 yr 5 mo
Pharmaceutical detail
Active ingredient
ORFORGLIPRON CALCIUM
Strength
EQ 0.8MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 220934
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
Apr 01, 2031
in 4 yr 10 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE50455 | Sep 26, 2037 | in 11 yr 5 mo | SubstanceProductU-4474 |
