Prescription medicine
Iloprost Brand names: Aurlumyn; first approved as Ventavis
Iloprost (Ventavis) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the iloprost FDA label on DailyMed (effective August 13, 2026, BTG International Inc); the NDA 21779 record on Drugs@FDA; every iloprost label on DailyMed.
Highlights of the record
FDA label of August 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- December 29, 2004 Ventavis, Actelion; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 10, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 18, 2044 Aurlumyn 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)
- No recall recorded
- FAERS reports
- 923 through July 30, 2026
What is iloprost used for?
From the label: indications and usageAURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes ( 1.1 ). 1.1 Frostbite AURLUMYN is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.
FDA pharmacologic class: Prostacycline.
Source: FDA drug label (AURLUMYN), NDA217933 (Btg Intl), as published by BTG International Inc, effective August 13, 2026 (SPL set 34036fc0-6832-d066-e063-6394a90a18a4), via openFDA; the full label on DailyMed
Is there a generic for iloprost (Ventavis)?
The FDA approved the first generic iloprost on July 10, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists no patent for Ventavis solution; a patent listed only for Aurlumyn injection runs to July 18, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2026 first generic approved
- 2044 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for iloprost?
The FDA Adverse Event Reporting System holds 923 reports that list iloprost among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 282 are coded as a death and 379 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 next?
- Iloprost side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other