FDA Orange Book
Generic for Ventavis
Ventavis 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
Yes. The generic name for Ventavis is iloprost. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 2 of the 3 Ventavis products the Orange Book lists.
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Ventavis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | 10MCG/ML (10MCG/ML) | Discontinued | None | 1 | None |
| solution, inhalation | 20MCG/2ML (10MCG/ML) | Discontinued | None | 0 | None |
| solution, inhalation | 20MCG/ML (20MCG/ML) | Discontinued | None | 1 | None |
NDA 021779, held by ACTELION PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic iloprost
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| REGCON HOLDINGS LLC | 214997 | None (No TE code listed) | July 10, 2026 | 10MCG/ML (10MCG/ML), 20MCG/ML (20MCG/ML) |
Questions
Is there a generic for Ventavis?
Yes. The generic name for Ventavis is iloprost. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 2 of the 3 Ventavis products the Orange Book lists.
What is the generic name for Ventavis?
The active ingredient in Ventavis is iloprost, per the FDA Orange Book.
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.