FDA Orange Book
Generic for Veletri
Veletri 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 Veletri 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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Veletri 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 | Marketed (Rx) | AP2 | 3 | AP2 |
| injectable, injection | EQ 1.5MG BASE/VIAL | Marketed (Rx) | AP2 | 3 | AP2 |
NDA 022260, 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 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 |
Veletri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8598227 | February 2, 2027 | Method of use | None | 022260 |
| 8318802 | March 15, 2027 | Drug product | None | 022260 |
Veletri NDC codes
Questions
Is there a generic for Veletri?
Yes. The generic name for Veletri 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 Veletri?
The active ingredient in Veletri is epoprostenol, per the FDA Orange Book.
When does the Veletri patent expire?
The last patent listed for Veletri in the Orange Book expires March 15, 2027. 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.