FDA Orange Book
Is there a generic for Kloxxado?
Kloxxado contains naloxone. 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 Kloxxado (naloxone). The Orange Book shows its last listed patent expires August 26, 2034.
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Kloxxado products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | 4MG/SPRAY | Discontinued | None | 0 | None |
| spray, nasal | 8MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 212045, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kloxxado patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11617713 | August 26, 2034 | Drug product | U-3110 | 212045 |
| 11628139 | August 26, 2034 | Drug product | U-3110 | 212045 |
| 10973814 | August 26, 2034 | Drug product | U-3110 | 212045 |
| 10722510 | August 26, 2034 | Drug product | U-3110 | 212045 |
| 11975096 | August 26, 2034 | Drug product | None | 212045 |
| 12414915 | August 26, 2034 | Drug product | None | 212045 |
| 11135155 | August 26, 2034 | Drug product | None | 212045 |
Kloxxado NDC codes
Questions
Is there a generic for Kloxxado?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kloxxado (naloxone). The Orange Book shows its last listed patent expires August 26, 2034.
What is the generic name for Kloxxado?
The active ingredient in Kloxxado is naloxone, per the FDA Orange Book.
When does the Kloxxado patent expire?
The last patent listed for Kloxxado in the Orange Book expires August 26, 2034. 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.