Orange Book product · Brand (NDA)

MACRILEN

MACIMORELIN ACETATE

Brand (NDA)NDA 205598DISCN AETERNA ZENTARIS

Dec 20, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 20, 2017
8 yr 7 mo ago
Today
Patent 8192719 expires
Listed method-of-use patent (U-2220) expiration.
Oct 12, 2027
in 1 yr 4 mo
Patent 8192719*PED expires
Listed listed patent expiration.
Apr 12, 2028
in 1 yr 10 mo

Active ingredient

MACIMORELIN ACETATE

Strength

EQ 60MG BASE/POUCH

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 205598

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8192719	Oct 12, 2027	in 1 yr 4 mo	U-2220
8192719*PED	Apr 12, 2028	in 1 yr 10 mo