FDA Orange Book
Is there a generic for Lumason?
Lumason contains sulfur hexafluoride lipid-type a microspheres. 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 Lumason (sulfur hexafluoride lipid-type a microspheres). The Orange Book shows its last listed patent expires May 15, 2039.
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Lumason products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, intravenous | 60.7MG/25MG | Marketed (Rx) | None | 0 | None |
NDA 203684, held by BRACCO DIAGNOSTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lumason patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10232061 | July 6, 2038 | Drug product | None | 203684 |
| 10335502 | July 6, 2038 | Drug product | None | 203684 |
| 11723869 | May 15, 2039 | Drug product | U-3666 | 203684 |
| 11723869 | May 15, 2039 | Drug product | U-3667 | 203684 |
| 11723869 | May 15, 2039 | Drug product | U-3668 | 203684 |
Lumason NDC codes
Questions
Is there a generic for Lumason?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lumason (sulfur hexafluoride lipid-type a microspheres). The Orange Book shows its last listed patent expires May 15, 2039.
What is the generic name for Lumason?
The active ingredient in Lumason is sulfur hexafluoride lipid-type a microspheres, per the FDA Orange Book.
When does the Lumason patent expire?
The last patent listed for Lumason in the Orange Book expires May 15, 2039. 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.