FDA Orange Book
Is there a generic for Neuraceq?
Neuraceq contains florbetaben f-18. 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 Neuraceq (florbetaben f-18). The Orange Book shows its last listed patent expires July 14, 2032.
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Neuraceq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1.4-135mCi/ML | Marketed (Rx) | None | 0 | None |
NDA 204677, held by LANTHEUS BIOSCIENCES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Neuraceq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7807135 | March 18, 2029 | Drug substance, Drug product | U-1497 | 204677 |
| 9308284 | July 14, 2032 | Drug product | None | 204677 |
Neuraceq NDC codes
Questions
Is there a generic for Neuraceq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Neuraceq (florbetaben f-18). The Orange Book shows its last listed patent expires July 14, 2032.
What is the generic name for Neuraceq?
The active ingredient in Neuraceq is florbetaben f-18, per the FDA Orange Book.
When does the Neuraceq patent expire?
The last patent listed for Neuraceq in the Orange Book expires July 14, 2032. 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.