FDA Orange Book
Is there a generic for Secuado?
Secuado contains asenapine. 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 Secuado (asenapine). The Orange Book shows its last listed patent expires September 22, 2033.
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Secuado products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, transdermal | 3.8MG/24HR | Marketed (Rx) | None | 0 | None |
| system, transdermal | 5.7MG/24HR | Marketed (Rx) | None | 0 | None |
| system, transdermal | 7.6MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 212268, held by HISAMITSU PHARMACEUTICAL CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Secuado patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10583121 | July 25, 2033 | Drug product | U-2763 | 212268 |
| 10814002 | July 25, 2033 | Drug product | U-2763 | 212268 |
| 10022445 | July 25, 2033 | Drug product | None | 212268 |
| 11123305 | July 25, 2033 | Drug product | None | 212268 |
| 9687474 | July 25, 2033 | Drug product | None | 212268 |
| 11813364 | September 22, 2033 | Drug product | None | 212268 |
Secuado NDC codes
Questions
Is there a generic for Secuado?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Secuado (asenapine). The Orange Book shows its last listed patent expires September 22, 2033.
What is the generic name for Secuado?
The active ingredient in Secuado is asenapine, per the FDA Orange Book.
When does the Secuado patent expire?
The last patent listed for Secuado in the Orange Book expires September 22, 2033. 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.