FDA Orange Book
Is there a generic for Aurlumyn?
Aurlumyn contains iloprost. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aurlumyn (iloprost). The Orange Book shows its last listed patent expires July 18, 2044 and its last listed exclusivity ends February 13, 2031.
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Aurlumyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MCG/ML (100MCG/ML) | Marketed (Rx) | None | 0 | None |
NDA 217933, held by BTG INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aurlumyn patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12409184 | August 6, 2041 | Drug product | None | 217933 |
| 12409183 | July 18, 2044 | Method of use | U-4263 | 217933 |
Aurlumyn exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | February 13, 2027 | 217933 |
| ODE-465 | Orphan drug exclusivity | February 13, 2031 | 217933 |
Aurlumyn NDC codes
Questions
Is there a generic for Aurlumyn?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aurlumyn (iloprost). The Orange Book shows its last listed patent expires July 18, 2044 and its last listed exclusivity ends February 13, 2031.
What is the generic name for Aurlumyn?
The active ingredient in Aurlumyn is iloprost, per the FDA Orange Book.
When does the Aurlumyn patent expire?
The last patent listed for Aurlumyn in the Orange Book expires July 18, 2044. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.