FDA Orange Book
Is there a generic for Crenessity?
Crenessity contains crinecerfont. 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 Crenessity (crinecerfont). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends December 13, 2031.
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Crenessity products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 25MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 50MG | Marketed (Rx) | None | 0 | None |
| solution, oral | 50MG/ML | Marketed (Rx) | None | 0 | None |
NDA 218808, 218820, held by NEUROCRINE BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Crenessity patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10905690 | January 21, 2035 | Method of use | U-4049 | 218808 |
| 11311544 | January 21, 2035 | Method of use | U-4049 | 218808 |
| 11730739 | January 21, 2035 | Method of use | U-4049 | 218808 |
| 12128033 | June 9, 2041 | Drug substance | U-4049 | 218808 |
| 12582634 | January 12, 2043 | Drug substance | None | 218808 |
Crenessity exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 13, 2029 | 218808 |
| ODE-503 | Orphan drug exclusivity | December 13, 2031 | 218808 |
Questions
Is there a generic for Crenessity?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Crenessity (crinecerfont). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends December 13, 2031.
What is the generic name for Crenessity?
The active ingredient in Crenessity is crinecerfont, per the FDA Orange Book.
When does the Crenessity patent expire?
The last patent listed for Crenessity in the Orange Book expires January 12, 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.