FDA Orange Book
Is there a generic for Recorlev?
Recorlev contains levoketoconazole. 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 Recorlev (levoketoconazole). The Orange Book shows its last listed patent expires March 2, 2040 and its last listed exclusivity ends December 30, 2028.
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Recorlev products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 214133, held by STRONGBRIDGE DUBLIN LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Recorlev patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11478471 | January 10, 2026 | Method of use | U-3283 | 214133 |
| 10835530 | January 10, 2026 | Method of use | U-3283 | 214133 |
| 10517868 | January 10, 2026 | Method of use | U-3283 | 214133 |
| 10098877 | January 10, 2026 | Method of use | U-3283 | 214133 |
| 9918984 | May 3, 2028 | Method of use | U-3283 | 214133 |
| 12377096 | March 2, 2040 | Method of use | U-4236 | 214133 |
| 11278547 | March 2, 2040 | Method of use | U-3282 | 214133 |
| 11903940 | March 2, 2040 | Method of use | U-3821 | 214133 |
| 11020393 | March 2, 2040 | Method of use | U-3282 | 214133 |
Recorlev exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE* | See the Orange Book exclusivity code list | December 30, 2026 | 214133 |
| ODE-385 | Orphan drug exclusivity | December 30, 2028 | 214133 |
Recorlev NDC codes
Questions
Is there a generic for Recorlev?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Recorlev (levoketoconazole). The Orange Book shows its last listed patent expires March 2, 2040 and its last listed exclusivity ends December 30, 2028.
What is the generic name for Recorlev?
The active ingredient in Recorlev is levoketoconazole, per the FDA Orange Book.
When does the Recorlev patent expire?
The last patent listed for Recorlev in the Orange Book expires March 2, 2040. 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.