FDA Orange Book
Is there a generic for Terlivaz?
Terlivaz contains terlipressin acetate. 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 Terlivaz (terlipressin acetate). The Orange Book shows its last listed patent expires April 5, 2037 and its last listed exclusivity ends September 14, 2029.
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Terlivaz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 0.85MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 022231, held by MALLINCKRODT PHARMACEUTICALS IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Terlivaz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10335452 | April 5, 2037 | Method of use | U-3711 | 022231 |
Terlivaz exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 14, 2027 | 022231 |
| ODE-406 | Orphan drug exclusivity | September 14, 2029 | 022231 |
Terlivaz NDC codes
Questions
Is there a generic for Terlivaz?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Terlivaz (terlipressin acetate). The Orange Book shows its last listed patent expires April 5, 2037 and its last listed exclusivity ends September 14, 2029.
What is the generic name for Terlivaz?
The active ingredient in Terlivaz is terlipressin acetate, per the FDA Orange Book.
When does the Terlivaz patent expire?
The last patent listed for Terlivaz in the Orange Book expires April 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.