FDA Orange Book
Is there a generic for Vizamyl?
Vizamyl contains flutemetamol 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 Vizamyl (flutemetamol f-18). The Orange Book shows its last listed patent expires September 16, 2028.
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Vizamyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 121.5mCi/30ML (4.05mCi/ML) | Marketed (Rx) | None | 0 | None |
| injectable, intravenous | 40.5mCi/10ML (4.05mCi/ML) | Discontinued | None | 0 | None |
NDA 203137, held by GE HEALTHCARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vizamyl patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8916131 | September 16, 2028 | Drug product | None | 203137 |
Vizamyl NDC codes
Questions
Is there a generic for Vizamyl?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vizamyl (flutemetamol f-18). The Orange Book shows its last listed patent expires September 16, 2028.
What is the generic name for Vizamyl?
The active ingredient in Vizamyl is flutemetamol f-18, per the FDA Orange Book.
When does the Vizamyl patent expire?
The last patent listed for Vizamyl in the Orange Book expires September 16, 2028. 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.