Prescription medicine
Trofinetide Brand names: Daybue
Trofinetide (Daybue) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the trofinetide FDA label on DailyMed (effective September 4, 2026, Acadia Pharmaceuticals Inc.); the NDA 217026 record on Drugs@FDA; every trofinetide label on DailyMed.
Highlights of the record
FDA label of September 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
Forms and strengths
- 5000 mg
- 6000 mg
- 8000 mg
- 200 mg/ml
For solution; solution.
On the market
- Earliest approval on file
- March 10, 2023 Daybue, Acadia Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 12, 2043 Daybue Stix for solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,691 through July 30, 2026
What is trofinetide used for?
From the label: indications and usageDAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
Source: FDA drug label (Daybue), Acadia Pharmaceuticals Inc., effective September 4, 2026 (SPL set 67e6f2d9-21f6-466f-9def-826c6a4b8257), via openFDA; the full label on DailyMed
Is there a generic for trofinetide (Daybue)?
No generic trofinetide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Daybue Stix for solution: the compound patent runs to July 12, 2042 (pediatric exclusivity to January 12, 2043). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for trofinetide?
The FDA Adverse Event Reporting System holds 6,691 reports that list trofinetide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 39 are coded as a death and 802 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,524, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Trofinetide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other