FDA Orange Book
Is there a generic for Tyvaso?
Tyvaso 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 Tyvaso (treprostinil). The Orange Book shows its last listed patent expires February 3, 2042.
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Tyvaso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | 0.6MG/ML | Marketed (Rx) | None | 0 | None |
NDA 022387, 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.
Tyvaso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10376525 | May 14, 2027 | Method of use | U-1849 | 022387 |
| 9339507 | March 10, 2028 | Drug product | None | 022387 |
| 9358240 | May 5, 2028 | Method of use | U-1849 | 022387 |
| 9593066 | December 15, 2028 | Drug substance | None | 022387 |
| 11723887 | December 15, 2028 | Drug substance | None | 022387 |
| 11826327 | February 3, 2042 | Method of use | U-3749 | 022387 |
Tyvaso NDC codes
Questions
Is there a generic for Tyvaso?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tyvaso (treprostinil). The Orange Book shows its last listed patent expires February 3, 2042.
What is the generic name for Tyvaso?
The active ingredient in Tyvaso is treprostinil, per the FDA Orange Book.
When does the Tyvaso patent expire?
The last patent listed for Tyvaso in the Orange Book expires February 3, 2042. 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.