FDA Orange Book
Is there a generic for Lumisight?
Lumisight contains pegulicianine acetate. 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 Lumisight (pegulicianine acetate). The Orange Book shows its last listed patent expires September 14, 2034 and its last listed exclusivity ends April 17, 2029.
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Lumisight products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 39MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 214511, held by LUMICELL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lumisight patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11592396 | September 1, 2030 | Drug substance | None | 214511 |
| 9155471 | October 12, 2031 | Method of use | U-3890 | 214511 |
| 10285759 | December 8, 2031 | Method of use | U-3890 | 214511 |
| 9532835 | December 8, 2031 | Method of use | U-3890 | 214511 |
| 9032965 | December 8, 2031 | Method of use | U-3890 | 214511 |
| 9763577 | September 14, 2034 | Drug substance, Drug product | U-3890 | 214511 |
Lumisight exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 17, 2029 | 214511 |
Lumisight NDC codes
Questions
Is there a generic for Lumisight?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lumisight (pegulicianine acetate). The Orange Book shows its last listed patent expires September 14, 2034 and its last listed exclusivity ends April 17, 2029.
What is the generic name for Lumisight?
The active ingredient in Lumisight is pegulicianine acetate, per the FDA Orange Book.
When does the Lumisight patent expire?
The last patent listed for Lumisight in the Orange Book expires September 14, 2034. 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.