Viewing data from:

MACRILEN

NDA

MACIMORELIN ACETATE | N205598 | AETERNA ZENTARIS GMBH

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayPED (+6 mo)

2027

2028

Today

Apr. 12, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 6, 2019	SUPPL -3	View Letter (PDF)
Dec 27, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 60MG BASE/POUCH

RLD

1 patent0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Dec 20, 2017

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8192719	Oct 12, 2027PED: Apr 12, 2028	PED	—	—		—

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Aeterna Zentaris listed patent 8,192,719 (with pediatric exclusivity designation) in the Orange Book for Macrilen (macimorelin acetate, NDA 205598).

New: New record