Table 1.
Active Ingredient (Proprietary Name; Applicant) |
Dosage Form (Route; Strength; Approval Date; Marketing Status) |
Marketing Exclusivity | Approved Indication |
---|---|---|---|
Trofinetide (Daybue; Acadia Pharmaceuticals) |
Solution (Oral; 200 mg/mL; 10 March 2023; Prescription) |
New chemical entity exclusivity expires on 10 March 2028; Orphan drug exclusivity expires on 10 March 2030 | Rett syndrome or symptoms thereof in patients of ≥2 years of age |