Last Updated: November 8, 2026

Details for New Drug Application (NDA): 205598

NDA 205598 describes MACRILEN, which is a drug marketed by Aeterna Zentaris and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the MACRILEN profile page.

The generic ingredient in MACRILEN is macimorelin acetate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the macimorelin acetate profile page.

Summary for 205598

Tradename:	MACRILEN
Applicant:	Aeterna Zentaris
Ingredient:	macimorelin acetate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205598

Generic Entry Date for 205598^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION Dosage: FOR 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: 205598

Mechanism of Action	Growth Hormone Secretagogue Receptor Agonists

Suppliers and Packaging for NDA: 205598

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598	NDA	Novo Nordisk	0169-1401	0169-1401-01	1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH
MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598	NDA	Aeterna Zentaris GmbH	58844-130	58844-130-01	1 POUCH in 1 CARTON (58844-130-01) / 60 mg in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 60MG BASE/POUCH
Approval Date:	Dec 20, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 23, 2029
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:	Jan 23, 2030
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	⤷ Start Trial	Patent Expiration:	Apr 12, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 205598

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aeterna Zentaris	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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