Orange Book product · Brand (NDA)
ERZOFRI
PALIPERIDONE PALMITATE
At a glance
Jul 26, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 26, 2024
1 yr 11 mo ago
Today
Patent 12128049 expires
Listed method-of-use patent (U-3968) expiration.
Oct 26, 2038
in 12 yr 6 mo
Patent 12128049 expires
Listed method-of-use patent (U-3969) expiration.
Oct 26, 2038
in 12 yr 6 mo
Patent 11666573 expires
Listed method-of-use patent (U-3968) expiration.
Sep 24, 2039
in 13 yr 6 mo
Patent 11666573 expires
Listed method-of-use patent (U-3969) expiration.
Sep 24, 2039
in 13 yr 6 mo
Pharmaceutical detail
Active ingredient
PALIPERIDONE PALMITATE
Strength
39MG/0.25ML (39MG/0.25ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 216352
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12128049 | Oct 26, 2038 | in 12 yr 6 mo | U-3968 |
| 12128049 | Oct 26, 2038 | in 12 yr 6 mo | U-3969 |
| 11666573 | Sep 24, 2039 | in 13 yr 6 mo | U-3968 |
| 11666573 | Sep 24, 2039 | in 13 yr 6 mo | U-3969 |
