Generic for Lotemax: Loteprednol Etabonate

Yes. The generic name for Lotemax is loteprednol etabonate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Lotemax products the Orange Book lists.

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Lotemax products in the Orange Book

Lotemax products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, ophthalmic	0.5%	Marketed (Rx)	AB	1	AB
ointment, ophthalmic	0.5%	Marketed (Rx)	None	0	None
suspension/drops, ophthalmic	0.5%	Marketed (Rx)	AB	5	AB
suspension/drops, ophthalmic	0.5%	Discontinued	None	5	AB

NDA 202872, 200738, 020583, 020841, 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 Lotemax
Company	ANDA	TE code	Approved	Strengths
SENTISS AG	207609	AB (A-rated, therapeutically equivalent)	April 17, 2019	0.5%, 0.5%
SENTISS AG	212080	AB (A-rated, therapeutically equivalent)	February 10, 2021	0.5%
SUN PHARMACEUTICAL INDUSTRIES LTD	212450	AB (A-rated, therapeutically equivalent)	February 26, 2021	0.5%, 0.5%
LUPIN LTD	215719	AB (A-rated, therapeutically equivalent)	April 24, 2024	0.5%, 0.5%
PADAGIS US LLC	215204	AB (A-rated, therapeutically equivalent)	January 29, 2025	0.5%, 0.5%
AMNEAL EU LTD	217484	AB (A-rated, therapeutically equivalent)	May 20, 2025	0.5%, 0.5%

Lotemax NDC codes

Questions

Is there a generic for Lotemax?

Yes. The generic name for Lotemax is loteprednol etabonate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Lotemax products the Orange Book lists.

What is the generic name for Lotemax?

The active ingredient in Lotemax 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.

Generic for Lotemax