FDA Orange Book
Is there a generic for Tryvio?
Tryvio contains aprocitentan. 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 Tryvio (aprocitentan). The Orange Book shows its last listed patent expires July 26, 2038 and its last listed exclusivity ends March 22, 2029.
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Tryvio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG | Marketed (Rx) | None | 0 | None |
NDA 217686, held by IDORSIA PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tryvio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8324232 | September 21, 2029 | Drug substance, Drug product | U-3878 | 217686 |
| 11174247 | November 6, 2037 | Method of use | U-3879 | 217686 |
| 12297189 | February 26, 2038 | Drug product | None | 217686 |
| 10919881 | February 26, 2038 | Drug substance, Drug product | None | 217686 |
| 11787782 | March 2, 2038 | Method of use | U-3877 | 217686 |
| 11680058 | July 26, 2038 | Method of use | U-3878 | 217686 |
Tryvio exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 22, 2029 | 217686 |
Tryvio NDC codes
Questions
Is there a generic for Tryvio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tryvio (aprocitentan). The Orange Book shows its last listed patent expires July 26, 2038 and its last listed exclusivity ends March 22, 2029.
What is the generic name for Tryvio?
The active ingredient in Tryvio is aprocitentan, per the FDA Orange Book.
When does the Tryvio patent expire?
The last patent listed for Tryvio in the Orange Book expires July 26, 2038. 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.