Details for New Drug Application (NDA): 217026

NDA 217026 describes DAYBUE, which is a drug marketed by Acadia Pharms Inc and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DAYBUE profile page.

The generic ingredient in DAYBUE is trofinetide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trofinetide profile page.

Summary for 217026

Tradename:	DAYBUE
Applicant:	Acadia Pharms Inc
Ingredient:	trofinetide
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 217026

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 217026

Mechanism of Action

Cytochrome P450 3A4 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors

Suppliers and Packaging for NDA: 217026

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAYBUE	trofinetide	SOLUTION;ORAL	217026	NDA	Acadia Pharmaceuticals Inc.	63090-660	63090-660-01	1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	200MG/ML
Approval Date:	Mar 10, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 10, 2028
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Sep 10, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Sep 10, 2030
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

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