Orange Book product · Brand (NDA)
YUTREPIA
TREPROSTINIL SODIUM
At a glance
May 23, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 23, 2025
1 yr 1 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
May 23, 2028
in 1 yr 11 mo
Patent 10898494 expires
Listed method-of-use patent (U-4200) expiration.
May 05, 2037
in 11 yr
Patent 11660304 expires
Listed method-of-use patent (U-4200) expiration.
May 05, 2037
in 11 yr
Patent 11712442 expires
Listed method-of-use patent (U-4200) expiration.
May 05, 2037
in 11 yr
Patent 11744835 expires
Listed drug product patent expiration.
May 05, 2037
in 11 yr
Patent 11744836 expires
Listed drug product patent expiration.
May 05, 2037
in 11 yr
Patent 12390475 expires
Listed drug product patent expiration.
May 05, 2037
in 11 yr
Pharmaceutical detail
Active ingredient
TREPROSTINIL SODIUM
Strength
EQ 0.053MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 213005
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
May 23, 2028
in 1 yr 11 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10898494 | May 05, 2037 | in 11 yr | U-4200 |
| 11660304 | May 05, 2037 | in 11 yr | U-4200 |
| 11712442 | May 05, 2037 | in 11 yr | U-4200 |
| 11744835 | May 05, 2037 | in 11 yr | Product |
| 11744836 | May 05, 2037 | in 11 yr | Product |
| 12390475 | May 05, 2037 | in 11 yr | Product |
