Orange Book product · Brand (NDA)
INVEGA HAFYERA
PALIPERIDONE PALMITATE
At a glance
Aug 30, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2021
4 yr 10 mo ago
Today
Patent 11304951 expires
Listed method-of-use patent (U-3349) expiration.
May 07, 2041
in 15 yr 1 mo
Patent 11324751 expires
Listed method-of-use patent (U-3359) expiration.
May 07, 2041
in 15 yr 1 mo
Patent 12208100 expires
Listed method-of-use patent (U-3359) expiration.
May 07, 2041
in 15 yr 1 mo
Patent 12208100 expires
Listed method-of-use patent (U-4110) expiration.
May 07, 2041
in 15 yr 1 mo
Patent 11666697 expires
Listed method-of-use patent (U-3626) expiration.
Nov 24, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
PALIPERIDONE PALMITATE
Strength
1.092GM/3.5ML (312MG/ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 207946
Product number
005
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11304951 | May 07, 2041 | in 15 yr 1 mo | U-3349 |
| 11324751 | May 07, 2041 | in 15 yr 1 mo | U-3359 |
| 12208100 | May 07, 2041 | in 15 yr 1 mo | U-3359 |
| 12208100 | May 07, 2041 | in 15 yr 1 mo | U-4110 |
| 11666697 | Nov 24, 2041 | in 15 yr 8 mo | U-3626 |
