Orange Book product · Brand (NDA)

PROMACTA KIT

ELTROMBOPAG OLAMINE

Brand (NDA)NDA 207027TE ABRX NOVARTIS

Sep 27, 2018

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 27, 2018
7 yr 10 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719*PED expires
Listed listed patent expiration.
Jan 13, 2026
5 mo ago
Today

Active ingredient

ELTROMBOPAG OLAMINE

Strength

EQ 12.5MG ACID/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Application

NDA 207027

Product number

002

Marketing status

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
7547719	Jul 13, 2025	11 mo ago	SubstanceProductU-2452
7547719	Jul 13, 2025	11 mo ago	SubstanceProductU-1736
7547719	Jul 13, 2025	11 mo ago	SubstanceProductU-1575
7547719	Jul 13, 2025	11 mo ago	SubstanceProductU-1306
7547719*PED	Jan 13, 2026	5 mo ago