Orange Book product · Brand (NDA)
RISVAN
RISPERIDONE
At a glance
Mar 29, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2024
2 yr 3 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Mar 29, 2027
in 9 mo
Patent 10058504 expires
Listed drug product patent expiration.
May 31, 2031
in 5 yr
Patent 10085936 expires
Listed drug product patent expiration.
May 31, 2031
in 5 yr
Patent 10182982 expires
Listed method-of-use patent (U-3943) expiration.
May 31, 2031
in 5 yr
Patent 10195138 expires
Listed method-of-use patent (U-3943) expiration.
May 31, 2031
in 5 yr
Patent 10335366 expires
Listed drug product patent expiration.
May 31, 2031
in 5 yr
Patent 10463607 expires
Listed drug product patent expiration.
May 31, 2031
in 5 yr
Patent 10881605 expires
Listed drug product patent expiration.
May 31, 2031
in 5 yr
Patent 11007139 expires
Listed method-of-use patent (U-3942) expiration.
May 31, 2031
in 5 yr
Patent 11173110 expires
Listed method-of-use patent (U-3941) expiration.
May 31, 2031
in 5 yr
Patent 11241377 expires
Listed method-of-use patent (U-3939) expiration.
May 31, 2031
in 5 yr
Patent 11752092 expires
Listed method-of-use patent (U-3941) expiration.
May 31, 2031
in 5 yr
Patent 11752093 expires
Listed drug product patent expiration.
May 31, 2031
in 5 yr
Patent 11752094 expires
Listed method-of-use patent (U-3942) expiration.
May 31, 2031
in 5 yr
Patent 11759416 expires
Listed method-of-use patent (U-3939) expiration.
May 31, 2031
in 5 yr
Pharmaceutical detail
Active ingredient
RISPERIDONE
Strength
100MG
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 214835
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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
- 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)
Mar 29, 2027
in 9 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10058504 | May 31, 2031 | in 5 yr | Product |
| 10085936 | May 31, 2031 | in 5 yr | Product |
| 10182982 | May 31, 2031 | in 5 yr | U-3943 |
| 10195138 | May 31, 2031 | in 5 yr | U-3943 |
| 10335366 | May 31, 2031 | in 5 yr | Product |
| 10463607 | May 31, 2031 | in 5 yr | Product |
| 10881605 | May 31, 2031 | in 5 yr | Product |
| 11007139 | May 31, 2031 | in 5 yr | U-3942 |
| 11173110 | May 31, 2031 | in 5 yr | U-3941 |
| 11241377 | May 31, 2031 | in 5 yr | U-3939 |
| 11752092 | May 31, 2031 | in 5 yr | U-3941 |
| 11752093 | May 31, 2031 | in 5 yr | Product |
| 11752094 | May 31, 2031 | in 5 yr | U-3942 |
| 11759416 | May 31, 2031 | in 5 yr | U-3939 |
