FDA Orange Book
Is there a generic for Levulan?
Levulan 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 Levulan (aminolevulinic acid). The Orange Book shows its last listed patent expires January 12, 2038.
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Levulan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, topical | 20% | Marketed (Rx) | None | 0 | None |
NDA 020965, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Levulan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12290700 | October 13, 2036 | Method of use | U-804 | 020965 |
| 11697028 | October 13, 2036 | Method of use | U-804 | 020965 |
| 11179574 | October 13, 2036 | Method of use | U-804 | 020965 |
| 11446512 | January 17, 2037 | Method of use | U-804 | 020965 |
| 11690914 | January 12, 2038 | Method of use | U-3163 | 020965 |
| 11077192 | January 12, 2038 | Method of use | U-3163 | 020965 |
| 12296011 | January 12, 2038 | Method of use | U-3163 | 020965 |
| 10357567 | January 12, 2038 | Method of use | U-3163 | 020965 |
| 11571478 | January 12, 2038 | Method of use | U-3163 | 020965 |
| 11135293 | January 12, 2038 | Method of use | U-3163 | 020965 |
Questions
Is there a generic for Levulan?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Levulan (aminolevulinic acid). The Orange Book shows its last listed patent expires January 12, 2038.
What is the generic name for Levulan?
The active ingredient in Levulan is aminolevulinic acid, per the FDA Orange Book.
When does the Levulan patent expire?
The last patent listed for Levulan in the Orange Book expires January 12, 2038. 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.