FDA Orange Book
Is there a generic for Tyvaso DPI?
Tyvaso DPI 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 DPI (treprostinil). The Orange Book shows its last listed patent expires February 3, 2042.
Run it in Rivvi
Map Tyvaso DPI and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Tyvaso DPI products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 0.016MG/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.032MG/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.048MG/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.064MG/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.08MG/INH | Marketed (Rx) | None | 0 | None |
NDA 214324, 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 DPI patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11357782 | May 14, 2027 | Method of use | U-1849 | 214324 |
| 9593066 | December 15, 2028 | Drug substance | None | 214324 |
| 11723887 | December 15, 2028 | Drug substance | None | 214324 |
| 10772883 | June 11, 2030 | Drug product | None | 214324 |
| 12679811 | March 14, 2034 | Method of use | U-1849 | 214324 |
| 12679811 | March 14, 2034 | Method of use | U-3749 | 214324 |
| 10421729 | April 1, 2035 | Drug product | None | 214324 |
| 11826327 | February 3, 2042 | Method of use | U-3749 | 214324 |
Tyvaso DPI NDC codes
Questions
Is there a generic for Tyvaso DPI?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tyvaso DPI (treprostinil). The Orange Book shows its last listed patent expires February 3, 2042.
What is the generic name for Tyvaso DPI?
The active ingredient in Tyvaso DPI is treprostinil, per the FDA Orange Book.
When does the Tyvaso DPI patent expire?
The last patent listed for Tyvaso DPI 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.
More on Tyvaso DPI and Treprostinil
- What is Tyvaso DPI used for?FDA label uses
- Is Tyvaso DPI a controlled substance?Federal schedule
- Generic for RemodulinFDA Orange Book
- Generic for YutrepiaFDA Orange Book
- Generic for TyvasoFDA Orange Book
- Prostacycline Vasodilators listFDA drug class
- Tyvaso DPI Medicare Part D coverageBy plan and state
- NDC 66302-616Tyvaso DPI NDC record
- NDC 66302-632Tyvaso DPI NDC record
- NDC 66302-648Tyvaso DPI NDC record