Orange Book product · Brand (NDA)

REMODULIN

TREPROSTINIL

Brand (NDA)NDA 021272DISCN UNITED THERAP

Jul 30, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 30, 2021
5 yr ago
Today
Patent 8653137 expires
Listed method-of-use patent (U-1437) expiration.
Sep 05, 2028
in 2 yr 3 mo
Patent 8658694 expires
Listed method-of-use patent (U-1437) expiration.
Sep 05, 2028
in 2 yr 3 mo
Patent 11723887 expires
Listed drug substance patent expiration.
Dec 15, 2028
in 2 yr 6 mo
Patent 9593066 expires
Listed drug substance patent expiration.
Dec 15, 2028
in 2 yr 6 mo
Patent 7999007 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo

Active ingredient

TREPROSTINIL

Strength

20MG/ML

Dosage form

INJECTABLE

Route

INTRAVENOUS, SUBCUTANEOUS

TE code

Not listed

Application

NDA 021272

Product number

005

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
8653137	Sep 05, 2028	in 2 yr 3 mo	U-1437
8658694	Sep 05, 2028	in 2 yr 3 mo	U-1437
11723887	Dec 15, 2028	in 2 yr 6 mo	Substance
9593066	Dec 15, 2028	in 2 yr 6 mo	Substance
7999007	Mar 29, 2029	in 2 yr 10 mo	ProductU-1437