FDA Orange Book
Is there a generic for Rezzayo?
Rezzayo contains rezafungin 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 Rezzayo (rezafungin acetate). The Orange Book shows its last listed patent expires July 14, 2038 and its last listed exclusivity ends March 22, 2035.
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Rezzayo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 200MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 217417, held by MUNDIPHARMA GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rezzayo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11654196 | March 2, 2032 | Drug substance, Drug product | U-3566 | 217417 |
| 10702573 | March 14, 2033 | Drug substance, Drug product | U-3566 | 217417 |
| 9526835 | March 14, 2033 | Drug substance, Drug product | U-3566 | 217417 |
| 8722619 | May 9, 2036 | Drug substance, Drug product | U-3566 | 217417 |
| 11712459 | March 15, 2037 | Drug product | U-3566 | 217417 |
| 11819533 | July 11, 2038 | Drug substance, Drug product | U-3566 | 217417 |
| 11197909 | July 14, 2038 | Drug substance, Drug product | U-3566 | 217417 |
Rezzayo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 22, 2028 | 217417 |
| ODE-426 | Orphan drug exclusivity | March 22, 2030 | 217417 |
| GAIN | Generating Antibiotic Incentives Now | March 22, 2033 | 217417 |
| GAIN | Generating Antibiotic Incentives Now | March 22, 2035 | 217417 |
Rezzayo NDC codes
Questions
Is there a generic for Rezzayo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rezzayo (rezafungin acetate). The Orange Book shows its last listed patent expires July 14, 2038 and its last listed exclusivity ends March 22, 2035.
What is the generic name for Rezzayo?
The active ingredient in Rezzayo is rezafungin acetate, per the FDA Orange Book.
When does the Rezzayo patent expire?
The last patent listed for Rezzayo in the Orange Book expires July 14, 2038. 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.