FDA Orange Book
Generic for Flolan
Flolan contains epoprostenol. 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 Flolan is epoprostenol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP2.
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Flolan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 0.5MG BASE/VIAL | Discontinued | None | 3 | AP2 |
| injectable, injection | EQ 1.5MG BASE/VIAL | Discontinued | None | 3 | AP2 |
NDA 020444, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic epoprostenol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 210473 | AP2 (A-rated, therapeutically equivalent) | January 15, 2021 | EQ 0.5MG BASE/VIAL, EQ 1.5MG BASE/VIAL |
| MYLAN PHARMACEUTICALS INC | 213913 | AP2 (A-rated, therapeutically equivalent) | June 12, 2024 | EQ 0.5MG BASE/VIAL, EQ 1.5MG BASE/VIAL |
| GLAND PHARMA LTD | 219237 | AP2 (A-rated, therapeutically equivalent) | December 29, 2025 | EQ 0.5MG BASE/VIAL, EQ 1.5MG BASE/VIAL |
Questions
Is there a generic for Flolan?
Yes. The generic name for Flolan is epoprostenol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP2.
What is the generic name for Flolan?
The active ingredient in Flolan is epoprostenol, 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.