FDA Orange Book
Generic for Loxitane
Loxitane contains loxapine. 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
Yes. The generic name for Loxitane is loxapine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 7 Loxitane products the Orange Book lists.
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Loxitane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 25MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 50MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 5MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 25MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Discontinued | None | 0 | None |
NDA 017525, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic loxapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 072205 | AB (A-rated, therapeutically equivalent) | June 15, 1988 | EQ 10MG BASE |
| WATSON LABORATORIES INC | 072206 | AB (A-rated, therapeutically equivalent) | June 15, 1988 | EQ 25MG BASE |
| WATSON LABORATORIES INC | 072062 | AB (A-rated, therapeutically equivalent) | June 15, 1988 | EQ 50MG BASE |
| WATSON LABORATORIES INC | 072204 | AB (A-rated, therapeutically equivalent) | June 15, 1988 | EQ 5MG BASE |
| ELITE LABORATORIES INC | 076868 | AB (A-rated, therapeutically equivalent) | August 4, 2005 | EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 5MG BASE |
| LANNETT CO INC | 090695 | AB (A-rated, therapeutically equivalent) | September 26, 2011 | EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 5MG BASE |
Questions
Is there a generic for Loxitane?
Yes. The generic name for Loxitane is loxapine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 7 Loxitane products the Orange Book lists.
What is the generic name for Loxitane?
The active ingredient in Loxitane is loxapine, per the FDA Orange Book.
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.