FDA Orange Book
Is there a generic for Yutrepia?
Yutrepia contains treprostinil. 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 Yutrepia (treprostinil). The Orange Book shows its last listed patent expires May 5, 2037 and its last listed exclusivity ends May 23, 2028.
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Yutrepia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | EQ 0.0265MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | EQ 0.053MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | EQ 0.0795MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | EQ 0.106MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 213005, held by LIQUIDIA TECHNOLOGIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Yutrepia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11712442 | May 5, 2037 | Method of use | U-4200 | 213005 |
| 10898494 | May 5, 2037 | Method of use | U-4200 | 213005 |
| 11660304 | May 5, 2037 | Method of use | U-4200 | 213005 |
| 12390475 | May 5, 2037 | Drug product | None | 213005 |
| 11744836 | May 5, 2037 | Drug product | None | 213005 |
| 11744835 | May 5, 2037 | Drug product | None | 213005 |
Yutrepia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | May 23, 2028 | 213005 |
Yutrepia NDC codes
Questions
Is there a generic for Yutrepia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Yutrepia (treprostinil). The Orange Book shows its last listed patent expires May 5, 2037 and its last listed exclusivity ends May 23, 2028.
What is the generic name for Yutrepia?
The active ingredient in Yutrepia is treprostinil, per the FDA Orange Book.
When does the Yutrepia patent expire?
The last patent listed for Yutrepia in the Orange Book expires May 5, 2037. 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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