Orange Book product · Brand (NDA)

VELETRI

EPOPROSTENOL SODIUM

Brand (NDA)NDA 022260TE AP2RX ACTELION

Jun 28, 2012

Approved

Brand (NDA)

Application

AP2

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 28, 2012
14 yr 2 mo ago
Today
Patent 8598227 expires
Listed listed patent expiration.
Feb 02, 2027
in 8 mo
Patent 8318802 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo

Active ingredient

EPOPROSTENOL SODIUM

Strength

EQ 0.5MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP2

Application

NDA 022260

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
8598227	Feb 02, 2027	in 8 mo
8318802	Mar 15, 2027	in 9 mo	Product