FDA Orange Book
Is there a generic for Cypsedo?
Cypsedo contains cipepofol. 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 Cypsedo (cipepofol). The Orange Book shows its last listed patent expires May 6, 2034 and its last listed exclusivity ends August 27, 2031.
Run it in Rivvi
Map Cypsedo and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Cypsedo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, intravenous | 50MG/20ML (2.5MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 220482, held by HAISCO-USA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cypsedo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10729666 | May 6, 2034 | Drug product | U-4599 | 220482 |
| 9517988 | May 6, 2034 | Drug substance | U-4599 | 220482 |
Cypsedo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 27, 2031 | 220482 |
Questions
Is there a generic for Cypsedo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cypsedo (cipepofol). The Orange Book shows its last listed patent expires May 6, 2034 and its last listed exclusivity ends August 27, 2031.
What is the generic name for Cypsedo?
The active ingredient in Cypsedo is cipepofol, per the FDA Orange Book.
When does the Cypsedo patent expire?
The last patent listed for Cypsedo in the Orange Book expires May 6, 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.