FDA Orange Book
Generic for Lotronex
Lotronex contains alosetron. 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 Lotronex is alosetron. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lotronex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.5MG BASE | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | EQ 1MG BASE | Marketed (Rx) | AB | 4 | AB |
NDA 021107, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic alosetron
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 206647 | AB (A-rated, therapeutically equivalent) | December 22, 2016 | EQ 0.5MG BASE, EQ 1MG BASE |
| RISING PHARMA HOLDINGS INC | 209180 | AB (A-rated, therapeutically equivalent) | January 14, 2019 | EQ 0.5MG BASE, EQ 1MG BASE |
| ADAPTIS PHARMA PRIVATE LTD | 211621 | AB (A-rated, therapeutically equivalent) | September 16, 2019 | EQ 0.5MG BASE, EQ 1MG BASE |
| MANKIND PHARMA LTD | 213614 | AB (A-rated, therapeutically equivalent) | September 9, 2020 | EQ 0.5MG BASE, EQ 1MG BASE |
Lotronex NDC codes
Questions
Is there a generic for Lotronex?
Yes. The generic name for Lotronex is alosetron. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lotronex?
The active ingredient in Lotronex is alosetron, 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.