FDA Orange Book
Is there a generic for Uzedy?
Uzedy 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 Uzedy (risperidone). The Orange Book shows its last listed patent expires March 17, 2042 and its last listed exclusivity ends April 28, 2026.
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Uzedy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, subcutaneous | 100MG/0.28ML (100MG/0.28ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, subcutaneous | 125MG/0.35ML (125MG/0.35ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, subcutaneous | 150MG/0.42ML (150MG/0.42ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, subcutaneous | 200MG/0.56ML (200MG/0.56ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, subcutaneous | 250MG/0.7ML (250MG/0.7ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, subcutaneous | 50MG/0.14ML (50MG/0.14ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, subcutaneous | 75MG/0.21ML (75MG/0.21ML) | Marketed (Rx) | None | 0 | None |
NDA 213586, held by TEVA NEUROSCIENCE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Uzedy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8221778 | November 12, 2027 | Drug product | U-601 | 213586 |
| 8221778 | November 12, 2027 | Drug product | U-543 | 213586 |
| 8741327 | November 12, 2027 | Drug product | U-543 | 213586 |
| 9023897 | April 5, 2033 | Drug product | None | 213586 |
| 12128132 | September 11, 2040 | Drug product | U-601 | 213586 |
| 12383493 | September 11, 2040 | Drug product | U-601 | 213586 |
| 12383493 | September 11, 2040 | Drug product | U-543 | 213586 |
| 12128132 | September 11, 2040 | Drug product | U-543 | 213586 |
| 12329851 | March 17, 2042 | Method of use | U-4214 | 213586 |
Uzedy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | April 28, 2026 | 213586 |
Uzedy NDC codes
Questions
Is there a generic for Uzedy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Uzedy (risperidone). The Orange Book shows its last listed patent expires March 17, 2042 and its last listed exclusivity ends April 28, 2026.
What is the generic name for Uzedy?
The active ingredient in Uzedy is risperidone, per the FDA Orange Book.
When does the Uzedy patent expire?
The last patent listed for Uzedy in the Orange Book expires March 17, 2042. 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.
More on Uzedy and Risperidone
- What is Uzedy used for?FDA label uses
- Is Uzedy a controlled substance?Federal schedule
- What is Risperidone used for?FDA label uses
- Is Risperidone a controlled substance?Federal schedule
- Generic for RykindoFDA Orange Book
- Generic for Risperdal ConstaFDA Orange Book
- Generic for RisperdalFDA Orange Book
- Atypical Antipsychotics listFDA drug class
- NDC 51759-305Uzedy NDC record
- NDC 51759-410Uzedy NDC record
- NDC 51759-520Uzedy NDC record