Prescription medicine
Treprostinil Brand names: Tyvaso, Orenitram, Remodulin, Yutrepia
Treprostinil (Remodulin) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
Check it at the source: the treprostinil FDA label on DailyMed (effective February 13, 2025, Alembic Pharmaceuticals Inc.); the NDA 21272 record on Drugs@FDA; every treprostinil label on DailyMed.
Highlights of the record
FDA label of February 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTreprostinil injection is a prostacyclin mimetic indicated for:
Treatment of pulmonary arterial hypertension (PAH;
Forms and strengths
- 0.125 mg
- 0.25 mg
- 1 mg
- 2.5 mg
- 5 mg
- 1.74 mg/2.9ml
- 8 mg/20ml
- 20 mg/20ml
- 50 mg/20ml
- 100 mg/20ml
- 200 mg/20ml
Injection (solution); kit; inhalant; extended-release tablet; capsule.
On the market
- Earliest approval on file
- May 21, 2002 Remodulin, United Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first November 30, 2017; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- March 29, 2029 Remodulin injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2018 1 Class I among all firms' recalls; latest August 14, 2018; 1 more by firms not listed as its makers
- FAERS reports
- 124,759 through July 30, 2026
What is treprostinil used for?
From the label: indications and usageTreprostinil injection is a prostacyclin mimetic indicated for:
Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1)
Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. […]
Conditions named in the indications of treprostinil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Prostacycline Vasodilator.
Source: FDA drug label (Treprostinil), Alembic Pharmaceuticals Inc., effective February 13, 2025 (SPL set 4a684b13-669d-4721-8ed4-30cc7762b0b8), via openFDA; the full label on DailyMed
Is there a generic for treprostinil (Remodulin)?
The FDA approved the first generic treprostinil on November 30, 2017. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists treprostinil from 4 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 5 patents for Remodulin injection: the compound patent runs to December 15, 2028, and the last listed entry to March 29, 2029; a patent listed only for Tyvaso Dpi powder runs to February 3, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 2017 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has treprostinil been recalled?
The FDA's Enforcement Report lists 2 recalls naming treprostinil since 2018: 1 Class I (the most serious), 0 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of treprostinil and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 4, 2024 | Class I | Par Sterile Products LLC not a listed maker | Presence of Particulate Matter. |
| August 14, 2018 | Class III | United Therapeutics Corp. | Defective Delivery System: Water ingress through the lower water cup sensor of the device. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the treprostinil label say about other medicines?
The treprostinil label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Drugs on Treprostinil Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. |
| Bosentan | drug interactions | DRUG INTERACTIONS 7.1 Bosentan In a human pharmacokinetic study conducted with bosentan (250 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and bosentan were observed. |
| Fluconazole | drug interactions | Drugs on Treprostinil Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. |
| Gemfibrozil | drug interactions | Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil increases exposure (both C max and AUC) to treprostinil. |
| Glycine | warnings and precautions | Administration of IV Treprostinil injection with a high pH glycine diluent has been associated with a lower incidence of BSIs when compared to neutral diluents (sterile water, 0.9% sodium chloride) when used along with catheter care guidelines. |
| Rifampin | drug interactions | Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to treprostinil. |
| Sildenafil | drug interactions | In a human pharmacokinetic study conducted with sildenafil (60 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and sildenafil were observed. |
| Warfarin | drug interactions | Drugs on Treprostinil Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. |
Source: FDA drug label (Treprostinil), Alembic Pharmaceuticals Inc., effective February 13, 2025 (SPL set 4a684b13-669d-4721-8ed4-30cc7762b0b8), via openFDA; the full label on DailyMed
What do FAERS reports show for treprostinil?
The FDA Adverse Event Reporting System holds 124,759 reports that list treprostinil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,973 are coded as a death and 51,473 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as treprostinil?
6 other medicines are given the same way (oral) and in the same FDA class as treprostinil or labeled mainly for the same use (pulmonary arterial hypertension), the same class first. Pulmonary arterial hypertension lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ambrisentan | Pulmonary arterial hypertension | 12 labelers | $8.02 per tablet 10 mg tablet | No current entry |
| Selexipag | Pulmonary arterial hypertension | 2 labelers | n/a | No current entry |
| Bosentan | Pulmonary arterial hypertension | 5 labelers | n/a | No current entry |
| Macitentan | Pulmonary arterial hypertension | 13 labelers | n/a | No current entry |
| Riociguat | Pulmonary arterial hypertension | 1 labeler | n/a | No current entry |
| Macitentan and tadalafil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as treprostinil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to treprostinil
- 6 medicines for the same use
- Other prostacycline vasodilators
- the pharmacologic class, with prices and generics
- Treprostinil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other