FDA Orange Book
Is there a generic for Aqneursa?
Aqneursa contains levacetylleucine. 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 Aqneursa (levacetylleucine). The Orange Book shows its last listed patent expires April 19, 2037 and its last listed exclusivity ends September 24, 2031.
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Aqneursa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 1GM/PACKET | Marketed (Rx) | None | 0 | None |
NDA 219132, held by INTRABIO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aqneursa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11400067 | April 19, 2037 | Method of use | U-4170 | 219132 |
| 12433862 | April 19, 2037 | Method of use | U-4284 | 219132 |
| 12433863 | April 19, 2037 | Method of use | U-4285 | 219132 |
| 12144792 | April 19, 2037 | Method of use | U-4603 | 219132 |
Aqneursa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 24, 2029 | 219132 |
| ODE-498 | Orphan drug exclusivity | September 24, 2031 | 219132 |
Aqneursa NDC codes
Questions
Is there a generic for Aqneursa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aqneursa (levacetylleucine). The Orange Book shows its last listed patent expires April 19, 2037 and its last listed exclusivity ends September 24, 2031.
What is the generic name for Aqneursa?
The active ingredient in Aqneursa is levacetylleucine, per the FDA Orange Book.
When does the Aqneursa patent expire?
The last patent listed for Aqneursa in the Orange Book expires April 19, 2037. 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.