Orange Book product · Brand (NDA)
PERSERIS KIT
RISPERIDONE
At a glance
Jul 27, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 2018
8 yr ago
Today
Patent 10406160 expires
Listed drug product patent expiration.
Jun 26, 2026
in 7 d
Patent 10058554 expires
Listed method-of-use patent (U-2363) expiration.
Sep 26, 2026
in 3 mo
Patent 9597402 expires
Listed drug product patent expiration.
Sep 26, 2026
in 3 mo
Patent 11110093 expires
Listed drug product patent expiration.
Nov 05, 2026
in 5 mo
Patent 10010612 expires
Listed drug product patent expiration.
Feb 13, 2028
in 1 yr 8 mo
Patent 10376590 expires
Listed method-of-use patent (U-2608) expiration.
Feb 13, 2028
in 1 yr 8 mo
Patent 11013809 expires
Listed drug product patent expiration.
Feb 13, 2028
in 1 yr 8 mo
Patent 11712475 expires
Listed method-of-use patent (U-3135) expiration.
Feb 13, 2028
in 1 yr 8 mo
Patent 9180197 expires
Listed drug product patent expiration.
Feb 13, 2028
in 1 yr 8 mo
Patent 9186413 expires
Listed method-of-use patent (U-543) expiration.
Feb 13, 2028
in 1 yr 8 mo
Pharmaceutical detail
Active ingredient
RISPERIDONE
Strength
120MG
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 210655
Product number
002
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.
- 2024RISVANBrand (NDA)
NDA 214835 · LABS FARMS ROVI SA
- 2023UZEDYBrand (NDA)
NDA 213586 · TEVA
- 2023RYKINDOBrand (NDA)
NDA 212849 · SHANDONG LUYE
- 2007RISPERDAL CONSTABrand (NDA)
NDA 021346 · JANSSEN PHARMS
- 2003RISPERDALBrand (NDA)
NDA 021444 · JANSSEN PHARMS
- 1999RISPERDALBrand (NDA)
NDA 020272 · JANSSEN PHARMS
- 1996RISPERDALBrand (NDA)
NDA 020588 · JANSSEN PHARMS
- 2025RISPERIDONEGeneric (ANDA)
ANDA 218586 · AMNEAL
- 2025RISPERIDONEGeneric (ANDA)
ANDA 211220 · NANOMI
- 2024RISPERIDONEGeneric (ANDA)
ANDA 205104 · IPCA LABS LTD
- 2023RISPERIDONEGeneric (ANDA)
ANDA 214068 · TEVA PHARMS USA INC
- 2015RISPERIDONEGeneric (ANDA)
ANDA 202386 · CHARTWELL MOLECULAR
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10406160 | Jun 26, 2026 | in 7 d | ProductU-2608 |
| 10058554 | Sep 26, 2026 | in 3 mo | U-2363 |
| 9597402 | Sep 26, 2026 | in 3 mo | Product |
| 11110093 | Nov 05, 2026 | in 5 mo | ProductU-3135 |
| 10010612 | Feb 13, 2028 | in 1 yr 8 mo | Product |
| 10376590 | Feb 13, 2028 | in 1 yr 8 mo | U-2608 |
| 11013809 | Feb 13, 2028 | in 1 yr 8 mo | ProductU-3135 |
| 11712475 | Feb 13, 2028 | in 1 yr 8 mo | U-3135 |
| 9180197 | Feb 13, 2028 | in 1 yr 8 mo | Product |
| 9186413 | Feb 13, 2028 | in 1 yr 8 mo | U-543 |
