FDA Orange Book
Is there a generic for Tralement?
Tralement contains zinc sulfate, cupric sulfate, manganese sulfate and selenious acid. 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 Tralement (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid). The Orange Book shows its last listed patent expires July 1, 2041.
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Tralement products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) | Marketed (Rx) | None | 0 | None |
NDA 209376, held by AMERICAN REGENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tralement patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12150957 | July 1, 2041 | Method of use | U-3899 | 209376 |
| 12150956 | July 1, 2041 | Method of use | U-3899 | 209376 |
| 11975022 | July 1, 2041 | Method of use | U-3899 | 209376 |
| 11998565 | July 1, 2041 | Drug product | None | 209376 |
| 11786548 | July 1, 2041 | Drug product | None | 209376 |
Tralement NDC codes
Questions
Is there a generic for Tralement?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tralement (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid). The Orange Book shows its last listed patent expires July 1, 2041.
What is the generic name for Tralement?
The active ingredient in Tralement is zinc sulfate, cupric sulfate, manganese sulfate and selenious acid, per the FDA Orange Book.
When does the Tralement patent expire?
The last patent listed for Tralement in the Orange Book expires July 1, 2041. 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.