FDA Orange Book
Is there a generic for Rykindo?
Rykindo contains risperidone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rykindo (risperidone). The Orange Book shows its last listed patent expires April 10, 2032.
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Rykindo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, extended release, intramuscular | 12.5MG | Discontinued | None | 0 | None |
| for suspension, extended release, intramuscular | 25MG | Marketed (Rx) | None | 0 | None |
| for suspension, extended release, intramuscular | 37.5MG | Discontinued | None | 0 | None |
| for suspension, extended release, intramuscular | 50MG | Discontinued | None | 0 | None |
NDA 212849, held by SHANDONG LUYE PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rykindo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10406161 | April 10, 2032 | Drug product | U-3513 | 212849 |
| 10098882 | April 10, 2032 | Drug product | U-3513 | 212849 |
| 9532991 | April 10, 2032 | Drug product | U-3513 | 212849 |
| 9446135 | April 10, 2032 | Drug product | U-3513 | 212849 |
| 11110094 | April 10, 2032 | Drug product | None | 212849 |
Questions
Is there a generic for Rykindo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rykindo (risperidone). The Orange Book shows its last listed patent expires April 10, 2032.
What is the generic name for Rykindo?
The active ingredient in Rykindo is risperidone, per the FDA Orange Book.
When does the Rykindo patent expire?
The last patent listed for Rykindo in the Orange Book expires April 10, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.