Prescription medicine
Selexipag Brand names: Uptravi
Selexipag (Uptravi) is a prescription medicine with an FDA approval on record since 2015. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the selexipag FDA label on DailyMed (effective May 28, 2026, Actelion Pharmaceuticals US, Inc.); the NDA 207947 record on Drugs@FDA; every selexipag label on DailyMed.
Highlights of the record
FDA label of May 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageUPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): In adults to delay disease progression and reduce the risk of hospitalization for PAH.
Forms and strengths
- 10ml
Film-coated tablet; coated tablet; kit; injection (powder) for solution.
On the market
- Earliest approval on file
- December 21, 2015 Uptravi, Actelion; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first December 21, 2022; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 1, 2037 Uptravi tablets; 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)
- No recall recorded
- FAERS reports
- 25,685 through July 30, 2026
What is selexipag used for?
From the label: indications and usageUPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): In adults to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Adult Patients UPTRAVI is indicated for the treatment of pulmonary arterial hypertension in adults (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. […]
Conditions named in the indications of selexipag's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Prostacyclin Receptor Agonist.
Source: FDA drug label (UPTRAVI), Actelion Pharmaceuticals US, Inc., effective May 28, 2026 (SPL set a7a23b87-f892-4e2c-8e2e-ebf841220f90), via openFDA; the full label on DailyMed
Is there a generic for selexipag (Uptravi)?
The FDA approved the first generic selexipag on December 21, 2022. 3 generic applications are approved; 2 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 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists selexipag from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Uptravi tablets: the compound patent runs to August 1, 2030 (pediatric exclusivity to February 1, 2031), and the last listed entry to June 1, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2022 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the selexipag label say about other medicines?
The selexipag label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name selexipag. 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 |
|---|---|---|
| Clopidogrel | drug interactions | DRUG INTERACTIONS Moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide) increase exposure to the active metabolite of UPTRAVI. |
| Deferasirox | drug interactions | DRUG INTERACTIONS Moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide) increase exposure to the active metabolite of UPTRAVI. |
| Gemfibrozil | contraindications | Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. |
| Rifampin | drug interactions | Reduce the dosing of UPTRAVI to once daily. ( 2.7 , 7.1 , 12.3 ) CYP2C8 inducers (e.g., rifampin) decrease exposure to the active metabolite. |
| Teriflunomide | drug interactions | DRUG INTERACTIONS Moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide) increase exposure to the active metabolite of UPTRAVI. |
Source: FDA drug label (UPTRAVI), Actelion Pharmaceuticals US, Inc., effective May 28, 2026 (SPL set a7a23b87-f892-4e2c-8e2e-ebf841220f90), via openFDA; the full label on DailyMed
What do FAERS reports show for selexipag?
The FDA Adverse Event Reporting System holds 25,685 reports that list selexipag among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,847 are coded as a death and 12,615 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 selexipag?
6 other medicines are given the same way (oral) and in the same FDA class as selexipag 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 |
| Treprostinil | Pulmonary arterial hypertension | none listed | 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to selexipag
- 6 medicines for the same use
- Selexipag side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other