FDA Orange Book
Is there a generic for Adasuve?
Adasuve contains loxapine. 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 Adasuve (loxapine). The Orange Book shows its last listed patent expires October 23, 2026.
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Adasuve products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 10MG | Marketed (Rx) | None | 0 | None |
NDA 022549, held by NOVA PNEUMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Adasuve patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8387612 | October 23, 2026 | Drug product | None | 022549 |
Adasuve NDC codes
Questions
Is there a generic for Adasuve?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Adasuve (loxapine). The Orange Book shows its last listed patent expires October 23, 2026.
What is the generic name for Adasuve?
The active ingredient in Adasuve is loxapine, per the FDA Orange Book.
When does the Adasuve patent expire?
The last patent listed for Adasuve in the Orange Book expires October 23, 2026. 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.