FDA Orange Book
Is there a generic for Cuvrior?
Cuvrior contains trientine tetrahydrochloride. 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 Cuvrior (trientine tetrahydrochloride). The Orange Book shows its last listed patent expires May 3, 2039 and its last listed exclusivity ends April 28, 2029.
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Cuvrior products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
NDA 215760, held by ORPHALAN SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cuvrior patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12358862 | May 3, 2039 | Drug substance, Drug product | U-4262 | 215760 |
| 12358861 | May 3, 2039 | Drug substance, Drug product | U-4262 | 215760 |
| 11072577 | May 3, 2039 | Method of use | U-3370 | 215760 |
| 12662445 | May 3, 2039 | Drug substance, Drug product | U-4262 | 215760 |
| 10988436 | May 3, 2039 | Drug substance | None | 215760 |
Cuvrior exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-401 | Orphan drug exclusivity | April 28, 2029 | 215760 |
Cuvrior NDC codes
Questions
Is there a generic for Cuvrior?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cuvrior (trientine tetrahydrochloride). The Orange Book shows its last listed patent expires May 3, 2039 and its last listed exclusivity ends April 28, 2029.
What is the generic name for Cuvrior?
The active ingredient in Cuvrior is trientine tetrahydrochloride, per the FDA Orange Book.
When does the Cuvrior patent expire?
The last patent listed for Cuvrior in the Orange Book expires May 3, 2039. 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.