NDAORALFOR SOLUTION
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
4
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
Indications (2)
Clinical Trials (4)
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Started Sep 2021
15 enrolled
Rett Syndrome
Open-Label Extension Study of Trofinetide for Rett Syndrome
Started Nov 2020
77 enrolled
Rett Syndrome
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
Started Jan 2020
154 enrolled
Rett Syndrome
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
Started Nov 2019
187 enrolled
Rett Syndrome
Loss of Exclusivity
LOE Date
Jan 12, 2043
205 months away
Patent Expiry
Jan 12, 2043
Exclusivity Expiry
Sep 10, 2030
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9212204 | Jan 27, 2032 | U-3556 | |
| 9212204*PED | Jul 27, 2032 | — | |
| 11370755 | Aug 3, 2040 | SubstanceProduct | — |
| 11370755*PED | Feb 3, 2041 | — | |
| 12492167 | Jul 12, 2042 | SubstanceProduct | U-3556 |