FDA Orange Book

Generic for Alrex

Alrex contains loteprednol etabonate. 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 Alrex is loteprednol etabonate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Alrex products in the Orange Book

Alrex products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension/drops, ophthalmic	0.2%	Marketed (Rx)	AB	4	AB

NDA 020803, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic loteprednol etabonate

Approved generic versions of Alrex
Company	ANDA	TE code	Approved	Strengths
SENTISS AG	215933	AB (A-rated, therapeutically equivalent)	April 12, 2023	0.2%
LUPIN LTD	215550	AB (A-rated, therapeutically equivalent)	December 26, 2023	0.2%
PADAGIS US LLC	215203	AB (A-rated, therapeutically equivalent)	July 10, 2024	0.2%
AMNEAL EU LTD	216345	AB (A-rated, therapeutically equivalent)	December 13, 2024	0.2%

Alrex NDC codes

Questions

Is there a generic for Alrex?

Yes. The generic name for Alrex is loteprednol etabonate. 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 Alrex?

The active ingredient in Alrex is loteprednol etabonate, 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.