Orange Book product · Brand (NDA)
UZEDY
RISPERIDONE
At a glance
Apr 28, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2023
3 yr 2 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Apr 28, 2026
2 mo ago
Today
Patent 8221778 expires
Listed drug product patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8221778 expires
Listed drug product patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8741327 expires
Listed drug product patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 9023897 expires
Listed drug product patent expiration.
Apr 05, 2033
in 6 yr 11 mo
Patent 12128132 expires
Listed drug product patent expiration.
Sep 11, 2040
in 14 yr 5 mo
Patent 12128132 expires
Listed drug product patent expiration.
Sep 11, 2040
in 14 yr 5 mo
Patent 12383493 expires
Listed drug product patent expiration.
Sep 11, 2040
in 14 yr 5 mo
Patent 12383493 expires
Listed drug product patent expiration.
Sep 11, 2040
in 14 yr 5 mo
Patent 12329851 expires
Listed method-of-use patent (U-4214) expiration.
Mar 17, 2042
in 16 yr
Pharmaceutical detail
Active ingredient
RISPERIDONE
Strength
50MG/0.14ML (50MG/0.14ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 213586
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.
- 2024RISVANBrand (NDA)
NDA 214835 · LABS FARMS ROVI SA
- 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
- 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
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Apr 28, 2026
2 mo ago
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8221778 | Nov 12, 2027 | in 1 yr 5 mo | ProductU-601 |
| 8221778 | Nov 12, 2027 | in 1 yr 5 mo | ProductU-543 |
| 8741327 | Nov 12, 2027 | in 1 yr 5 mo | ProductU-543 |
| 9023897 | Apr 05, 2033 | in 6 yr 11 mo | Product |
| 12128132 | Sep 11, 2040 | in 14 yr 5 mo | ProductU-601 |
| 12128132 | Sep 11, 2040 | in 14 yr 5 mo | ProductU-543 |
| 12383493 | Sep 11, 2040 | in 14 yr 5 mo | ProductU-601 |
| 12383493 | Sep 11, 2040 | in 14 yr 5 mo | ProductU-543 |
| 12329851 | Mar 17, 2042 | in 16 yr | U-4214 |
