FDA Orange Book

Generic for Lotemax SM

Lotemax SM 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 Lotemax SM is loteprednol etabonate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Lotemax SM and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Lotemax SM products in the Orange Book

Lotemax SM products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, ophthalmic	0.38%	Marketed (Rx)	AB	1	AB

NDA 208219, 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 SM
Company	ANDA	TE code	Approved	Strengths
LUPIN LTD	218087	AB (A-rated, therapeutically equivalent)	June 30, 2025	0.38%

Lotemax SM patents

Patents listed for Lotemax SM
Patent	Expires	Covers	Use code	NDA
11534395	January 26, 2036	Drug product	U-2764	208219
12589069	January 26, 2036	Drug product	U-2764	208219
10596107	December 23, 2036	Drug product	U-2764	208219

Lotemax SM NDC codes

24208-507

Questions

Is there a generic for Lotemax SM?

Yes. The generic name for Lotemax SM is loteprednol etabonate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Lotemax SM?

The active ingredient in Lotemax SM is loteprednol etabonate, per the FDA Orange Book.

When does the Lotemax SM patent expire?

The last patent listed for Lotemax SM in the Orange Book expires December 23, 2036. 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.