Treprostinil
As of the edition of 20 October 2026, Treprostinil is a small molecule: marketed, first approved in 2002 (US); acts on PTGIR; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Remodulin
- First approved
- 21 May 2002 (US)
- Approvals on record
- 38 in 6 regions
- Holder of the most recent approval
- PINT PHARMA PRODUTOS MEDICO-HOSPITALARES E FARMACEUTICOS LTDA; 6 holders in all
- Registered trials
- 97, 26 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Skin and connective tissue; Inherited and neonatal; Immune system; Nutrition and metabolism
US protection
US protection ends in 2028.
The last listed US drug-substance patent ends in 2028. The application that gives this date is held by United Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product57 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Treprostinil.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGIR | Prostacyclin receptor | P43119 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 2 | 3 | 2 |
| Phase 1 | 19 | 17 | 2 | 0 |
| Phase 2 | 23 | 10 | 5 | 7 |
| Phase 3 | 28 | 11 | 6 | 11 |
| Phase 4 | 19 | 8 | 4 | 6 |
| All trials | 97 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| United Therapeutics | Originator and Lead sponsor of trials | 1998 to now |
| SciPharm SàRL | Applicant and Lead sponsor of trials | 2009 to now |
| Mochida Pharmaceutical | Applicant | 2014 to now |
| Liquidia Technologies | Later holder and Lead sponsor of trials | 2021 to now |