Orange Book product · Brand (NDA)

REMODULIN

TREPROSTINIL

Brand (NDA)NDA 208276DISCN UNITED THERAP

Jul 30, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 30, 2018
8 yr ago
Today
Patent 9593066 expires
Listed drug substance patent expiration.
Dec 15, 2028
in 2 yr 6 mo

Active ingredient

TREPROSTINIL

Strength

20MG/20ML (1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS, SUBCUTANEOUS

TE code

Not listed

Application

NDA 208276

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9593066	Dec 15, 2028	in 2 yr 6 mo	Substance