FDA Orange Book · active-ingredient family
Trofinetide
Trofinetide is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
16
Exclusivity periods
Brand (NDA) products · for solution, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAYBUE STIXRLD×3 | ACADIA PHARMS INC | NDA 219884 | — | Dec 11, 2025 | |
| DAYBUERLD | ACADIA PHARMS INC | NDA 217026 | — | Mar 10, 2023 |
Marketing exclusivity (16)
- NCENew chemical entity exclusivity (5 years)
Mar 10, 2028
in 1 yr 9 mo
- ODE*FDA marketing exclusivity
Mar 10, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2028
in 2 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Mar 10, 2028
in 1 yr 9 mo
- ODE*FDA marketing exclusivity
Mar 10, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2028
in 2 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Mar 10, 2028
in 1 yr 9 mo
- ODE*FDA marketing exclusivity
Mar 10, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2030
in 4 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2028
in 2 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Mar 10, 2028
in 1 yr 9 mo
- ODE-425Orphan-drug exclusivity (7 years)
Mar 10, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2030
in 4 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 10, 2028
in 2 yr 3 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9212204 | Jan 27, 2032 | in 5 yr 8 mo | U-3556 |
| 9212204*PED | Jul 27, 2032 | in 6 yr 2 mo | |
| 11370755 | Aug 03, 2040 | in 14 yr 4 mo | SubstanceProduct |
| 11370755*PED | Feb 03, 2041 | in 14 yr 10 mo | |
| 12492167 | Jul 12, 2042 | in 16 yr 4 mo | SubstanceProductU-3556 |
| 11827600 | Jul 12, 2042 | in 16 yr 4 mo | SubstanceProductU-3556 |
| 12492167*PED | Jan 12, 2043 | in 16 yr 10 mo | |
| 11827600*PED | Jan 12, 2043 | in 16 yr 10 mo |
Trofinetide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
