FDA Orange Book · active-ingredient family
Treprostinil
Treprostinil is approved as 4 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:REMODULIN · NDA 021272
4
Brand (NDA)
5
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REMODULINRLD×8 | UNITED THERAP | NDA 021272 | — | Sep 28, 2023 | |
| TYVASO DPIRLD×5 | UNITED THERAP | NDA 214324 | — | May 23, 2022 | |
| TYVASORLD | UNITED THERAP | NDA 022387 | — | Jul 30, 2009 | |
| REMODULIN×4 | UNITED THERAP | NDA 208276 | — | Jul 30, 2018 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TREPROSTINIL×4 | ALEMBIC GLOBAL | ANDA 211574 | AP | Feb 11, 2021 | |
| TREPROSTINIL×4 | DR REDDYS | ANDA 210214 | AP | May 22, 2020 | |
| TREPROSTINIL×4 | TEVA PHARMS USA | ANDA 206648 | AP | Sep 26, 2019 | |
| TREPROSTINIL×4 | PH HEALTH | ANDA 209382 | — | Sep 24, 2019 | |
| TREPROSTINIL×4 | SANDOZ | ANDA 203649 | AP | Nov 30, 2017 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11357782 | May 14, 2027 | in 11 mo | U-1849 |
| 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 |
| 8658694 | Sep 05, 2028 | in 2 yr 3 mo | U-1437 |
| 8653137 | 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 |
| 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 |
Treprostinil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
