FDA Orange Book
Is there a generic for Orenitram?
Orenitram contains treprostinil diolamine. 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 Orenitram (treprostinil diolamine). The Orange Book shows its last listed patent expires August 11, 2031 and its last listed exclusivity ends October 18, 2026.
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Orenitram products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 0.125MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 0.25MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 2.5MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 203496, held by UNITED THERAPEUTICS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orenitram patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9393203 | April 27, 2026 | Drug product | U-1877 | 203496 |
| 7417070 | July 30, 2026 | Drug substance | None | 203496 |
| 9604901 | December 15, 2028 | Drug substance | None | 203496 |
| 11723887 | December 15, 2028 | Drug substance | None | 203496 |
| 9593066 | December 15, 2028 | Drug substance | None | 203496 |
| 8497393 | December 15, 2028 | Drug substance | None | 203496 |
| 8410169 | February 13, 2030 | Drug product | None | 203496 |
| 8349892 | January 22, 2031 | Drug product | None | 203496 |
| 8747897 | August 11, 2031 | Drug product | U-2725 | 203496 |
| 8747897 | August 11, 2031 | Drug product | U-2724 | 203496 |
Orenitram exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-272 | Orphan drug exclusivity | October 18, 2026 | 203496 |
Orenitram NDC codes
Questions
Is there a generic for Orenitram?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orenitram (treprostinil diolamine). The Orange Book shows its last listed patent expires August 11, 2031 and its last listed exclusivity ends October 18, 2026.
What is the generic name for Orenitram?
The active ingredient in Orenitram is treprostinil diolamine, per the FDA Orange Book.
When does the Orenitram patent expire?
The last patent listed for Orenitram in the Orange Book expires August 11, 2031. 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.
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