Orange Book product · Brand (NDA)

TRACLEER

BOSENTAN

Brand (NDA)NDA 209279TE ABRX ACTELION

Sep 05, 2017

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 05, 2017
8 yr 11 mo ago
Patent 8309126 expires
Listed drug product patent expiration.
May 15, 2026
1 mo ago
Today
Patent 7959945 expires
Listed drug product patent expiration.
Dec 28, 2027
in 1 yr 7 mo

Active ingredient

BOSENTAN

Strength

32MG

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

TE code

Application

NDA 209279

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8309126	May 15, 2026	1 mo ago	Product
7959945	Dec 28, 2027	in 1 yr 7 mo	Product