Orange Book product · Generic (ANDA)
RISPERIDONE
RISPERIDONE
At a glance
Sep 02, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 02, 2025
10 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
May 09, 2026
1 mo ago
Today
Pharmaceutical detail
Active ingredient
RISPERIDONE
Strength
37.5MG/VIAL
Dosage form
POWDER
Route
INTRAMUSCULAR
TE code
AB
Application
ANDA 211220
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RISPERIDONE
- 2024RISVANBrand (NDA)
NDA 214835 · LABS FARMS ROVI SA
- 2023UZEDYBrand (NDA)
NDA 213586 · TEVA
- 2023RYKINDOBrand (NDA)
NDA 212849 · SHANDONG LUYE
- 2018PERSERIS KITBrand (NDA)
NDA 210655 · INDIVIOR
- 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
- 2024RISPERIDONEGeneric (ANDA)
ANDA 205104 · IPCA LABS LTD
- 2023RISPERIDONEGeneric (ANDA)
ANDA 214068 · TEVA PHARMS USA INC
- 2015RISPERIDONEGeneric (ANDA)
ANDA 202386 · CHARTWELL MOLECULAR
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
May 09, 2026
1 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
