Aurlumyn Generic: When Will Generic Iloprost Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Aurlumyn Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2031 About 4.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? July 2044 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic iloprost is expected to be available in February 2031, about 4.5 years away. None is for sale yet.
Why February 2031?
It is when Aurlumyn’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. We rate it probable: more likely than not, but it can still move.
If Aurlumyn’s last patent runs to July 2044, how can a generic come sooner?
The 2 patents that run past the expected month, to July 2044 (12,409,184 and 12,409,183), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Aurlumyn as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Aurlumyn by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2024 February 2024 FDA Orange Book
- Patents listed 2 last runs to July 2044 A generic is expected sooner, in February 2031. See why FDA Orange Book
Aurlumyn’s Road to a Generic
Aurlumyn has had the market to itself since the FDA approved it in February 2024 (Btg International Inc). Its FDA protection (orphan drug) runs to February 2031. Its 2 listed patents run to July 2044.
The first generic of Aurlumyn is expected in February 2031.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then. That is about 13.5 years before the last listed patent runs out, in July 2044.
Why a Generic Can Come Before July 2044
The last listed patent runs to July 2044, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Aurlumyn Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Aurlumyn’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,409,184 | The product’s formulation | August 2041 | Active |
| 12,409,183 | A way of using it (U-4263) | July 2044 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | February 2027 | Active |
| Orphan drug ODE-465 | Seven years of protection for a use in a rare disease. | February 2031 | Active |
Source: FDA Orange Book, application 217933. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Iloprost
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Aurlumyn yet.
Approved by the FDA
Not yet. The FDA has not approved a generic iloprost. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic iloprost for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Aurlumyn Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Aurlumyn, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
Aurlumyn Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MCG/ML (100MCG/ML) | Solution | Intravenous | February 2024 | Prescription reference product |
Source: FDA Orange Book, Btg International Inc. Listed for sale today by BTG International Inc (FDA NDC Directory).
Aurlumyn NDC Codes and Packages
Each Aurlumyn package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 50633-0340-01 | ILOPROST 100 ug/mL injection, solution | vial of 1 mL | BTG International Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Aurlumyn’s own FDA approval (NDA 217933) are listed, never a generic. Some codes belong to companies that repackage Aurlumyn: it is the same medicine in a different package.
What a Generic Aurlumyn Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Aurlumyn as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Aurlumyn”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Aurlumyn
Is there a generic for Aurlumyn right now?
No. As of October 9, 2026 no generic iloprost is listed for sale in the FDA NDC Directory.
When will Aurlumyn go generic?
February 2031 is the expected month, and that is probable but not certain. It is when Aurlumyn’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. The last listed patent runs to July 2044, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic iloprost be the same as Aurlumyn?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Aurlumyn?
Not yet. The FDA Orange Book lists no approved generic version of Aurlumyn.
When does the Aurlumyn patent expire?
The FDA Orange Book lists 2 patents for Aurlumyn; the last runs to July 2044. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (February 2031) weighs all of that.
Changes to This Projection
- First generic expected February 2031 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- ZTlidoLidocaineJuly to December 2026
- Hetlioz LQTasimelteonDecember 2027
- RayaldeeCalcifediolAugust 2028
- CometriqCabozantinib S-MalateFebruary 2032
- TyrvayaVarenicline TartrateOctober 2034
- MounjaroTirzepatideJanuary 2040
About Aurlumyn
- Generic name iloprost
- How it is taken Into a vein (IV)
- Company Btg International Inc
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Aurlumyn
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.