Orange Book product · Brand (NDA)

TYVASO DPI

TREPROSTINIL

Brand (NDA)NDA 214324RX UNITED THERAP

May 23, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 23, 2022
4 yr 2 mo ago
Today
Patent 11357782 expires
Listed method-of-use patent (U-1849) expiration.
May 14, 2027
in 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 10772883 expires
Listed drug product patent expiration.
Jun 11, 2030
in 4 yr
Patent 10421729 expires
Listed drug product patent expiration.
Apr 01, 2035
in 8 yr 11 mo
Patent 11826327 expires
Listed method-of-use patent (U-3749) expiration.
Feb 03, 2042
in 15 yr 10 mo

Active ingredient

TREPROSTINIL

Strength

0.064MG/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 214324

Product number

004

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
11357782	May 14, 2027	in 11 mo	U-1849
11723887	Dec 15, 2028	in 2 yr 6 mo	Substance
9593066	Dec 15, 2028	in 2 yr 6 mo	Substance
10772883	Jun 11, 2030	in 4 yr	Product
10421729	Apr 01, 2035	in 8 yr 11 mo	Product
11826327	Feb 03, 2042	in 15 yr 10 mo	U-3749