Orange Book product · Brand (NDA)

TYVASO

TREPROSTINIL

Brand (NDA)NDA 022387RX UNITED THERAP

Jul 30, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 30, 2009
17 yr 2 mo ago
Today
Patent 10376525 expires
Listed method-of-use patent (U-1849) expiration.
May 14, 2027
in 11 mo
Patent 9339507 expires
Listed drug product patent expiration.
Mar 10, 2028
in 1 yr 9 mo
Patent 9358240 expires
Listed method-of-use patent (U-1849) expiration.
May 05, 2028
in 1 yr 11 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 11826327 expires
Listed method-of-use patent (U-3749) expiration.
Feb 03, 2042
in 15 yr 10 mo

Active ingredient

TREPROSTINIL

Strength

0.6MG/ML

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

NDA 022387

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
10376525	May 14, 2027	in 11 mo	U-1849
9339507	Mar 10, 2028	in 1 yr 9 mo	Product
9358240	May 05, 2028	in 1 yr 11 mo	U-1849
11723887	Dec 15, 2028	in 2 yr 6 mo	Substance
9593066	Dec 15, 2028	in 2 yr 6 mo	Substance
11826327	Feb 03, 2042	in 15 yr 10 mo	U-3749