FDA Orange Book
Is there a generic for Cysview Kit?
Cysview Kit contains hexaminolevulinate. 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 Cysview Kit (hexaminolevulinate). The Orange Book shows its last listed patent expires January 4, 2038.
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Cysview Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, intravesical | 100MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 022555, held by PHOTOCURE ASA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cysview Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10556010 | December 19, 2036 | Method of use | U-2250 | 022555 |
| 11311620 | December 19, 2036 | Method of use | U-2250 | 022555 |
| 11235168 | January 4, 2038 | Method of use | U-2250 | 022555 |
Questions
Is there a generic for Cysview Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cysview Kit (hexaminolevulinate). The Orange Book shows its last listed patent expires January 4, 2038.
What is the generic name for Cysview Kit?
The active ingredient in Cysview Kit is hexaminolevulinate, per the FDA Orange Book.
When does the Cysview Kit patent expire?
The last patent listed for Cysview Kit in the Orange Book expires January 4, 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.