FDA Orange Book
Is there a generic for Ameluz?
Ameluz contains aminolevulinic acid. 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 Ameluz (aminolevulinic acid). The Orange Book shows its last listed patent expires December 8, 2043 and its last listed exclusivity ends October 4, 2027.
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Ameluz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 10% | Marketed (Rx) | None | 0 | None |
NDA 208081, held by BIOFRONTERA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ameluz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11540981 | February 7, 2028 | Drug product | None | 208081 |
| 11235169 | October 15, 2040 | Method of use | U-3303 | 208081 |
| 12280146 | December 8, 2043 | Drug product | None | 208081 |
Ameluz exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-194 | New dosing schedule | October 4, 2027 | 208081 |
Ameluz NDC codes
Questions
Is there a generic for Ameluz?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ameluz (aminolevulinic acid). The Orange Book shows its last listed patent expires December 8, 2043 and its last listed exclusivity ends October 4, 2027.
What is the generic name for Ameluz?
The active ingredient in Ameluz is aminolevulinic acid, per the FDA Orange Book.
When does the Ameluz patent expire?
The last patent listed for Ameluz in the Orange Book expires December 8, 2043. 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.