FDA Orange Book
Is there a generic for Cresemba?
Cresemba contains isavuconazonium. 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 Cresemba (isavuconazonium). The Orange Book shows its last listed patent expires March 14, 2028 and its last listed exclusivity ends June 8, 2031.
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Cresemba products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 186MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 74.5MG | Marketed (Rx) | None | 0 | None |
| powder, intravenous | 372MG | Marketed (Rx) | None | 0 | None |
NDA 207500, 207501, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cresemba patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6812238 | October 31, 2025 | Drug substance | None | 207500 |
| 6812238*PED | April 30, 2026 | Method of use | None | 207500 |
| 10603280 | September 14, 2027 | Drug product | None | 207500 |
| 10206879 | September 14, 2027 | Drug product | None | 207500 |
| 10603280*PED | March 14, 2028 | Method of use | None | 207500 |
| 10206879*PED | March 14, 2028 | Method of use | None | 207500 |
Cresemba exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | March 6, 2022 | 207500 |
| ODE-305 | Orphan drug exclusivity | March 6, 2022 | 207500 |
| ODE-90 | Orphan drug exclusivity | March 6, 2022 | 207500 |
| PED | Pediatric exclusivity | September 6, 2022 | 207500 |
| NPP | New patient population | December 8, 2026 | 207500 |
| PED | Pediatric exclusivity | June 8, 2027 | 207500 |
| GAIN | Generating Antibiotic Incentives Now | September 6, 2027 | 207500 |
| ODE-454 | Orphan drug exclusivity | December 8, 2030 | 207500 |
| ODE-458 | Orphan drug exclusivity | December 8, 2030 | 207500 |
| ODE-453 | Orphan drug exclusivity | December 8, 2030 | 207501 |
| ODE-459 | Orphan drug exclusivity | December 8, 2030 | 207501 |
| PED | Pediatric exclusivity | June 8, 2031 | 207500 |
Cresemba NDC codes
Questions
Is there a generic for Cresemba?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cresemba (isavuconazonium). The Orange Book shows its last listed patent expires March 14, 2028 and its last listed exclusivity ends June 8, 2031.
What is the generic name for Cresemba?
The active ingredient in Cresemba is isavuconazonium, per the FDA Orange Book.
When does the Cresemba patent expire?
The last patent listed for Cresemba in the Orange Book expires March 14, 2028. 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.