FDA Orange Book · active-ingredient family
Rezafungin acetate
Rezafungin acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:REZZAYO · NDA 217417
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
4
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REZZAYORLD | MUNDIPHARMA | NDA 217417 | — | Mar 22, 2023 |
Marketing exclusivity (4)
- NCENew chemical entity exclusivity (5 years)
Mar 22, 2028
in 1 yr 9 mo
- ODE-426Orphan-drug exclusivity (7 years)
Mar 22, 2030
in 3 yr 10 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Mar 22, 2035
in 8 yr 11 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Mar 22, 2033
in 6 yr 10 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11654196 | Mar 02, 2032 | in 5 yr 9 mo | SubstanceProductU-3566 |
| 10702573 | Mar 14, 2033 | in 6 yr 10 mo | SubstanceProductU-3566 |
| 9526835 | Mar 14, 2033 | in 6 yr 10 mo | SubstanceProductU-3566 |
| 8722619 | May 09, 2036 | in 10 yr | SubstanceProductU-3566 |
| 11712459 | Mar 15, 2037 | in 10 yr 11 mo | ProductU-3566 |
| 11819533 | Jul 11, 2038 | in 12 yr 3 mo | SubstanceProductU-3566 |
| 11197909 | Jul 14, 2038 | in 12 yr 3 mo | SubstanceProductU-3566 |
Rezafungin acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
