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LOTEMAX

NDA

LOTEPREDNOL ETABONATE | N202872 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

39 trials from ClinicalTrials.gov, 36 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.NCT01475643	Phase 3	Completed	Bausch & Lomb Incorporated	107	2013-06 → 2017-07
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis NCT03464435	Phase 4	Completed	Zhongshan Ophthalmic Center, Sun Yat-sen University	20	2016-11-01 → 2018-02-01
Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye NCT00560638	Phase 2	Completed	Bausch & Lomb Incorporated	119	2005-11 → 2006-02
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery NCT02208297	Phase 3	Completed	Bausch & Lomb Incorporated	326	2014-09 → 2015-03
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery NCT01060072	Phase 3	Completed	Bausch & Lomb Incorporated	407	2010-02 → 2010-10
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)NCT01435460	Phase 3	Completed	Bausch & Lomb Incorporated	300	2010-08 → 2011-05
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations NCT03098953	Phase 1	Completed	Bausch & Lomb Incorporated	15	2017-04-10 → 2017-05-12
Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium NCT04075227	Phase 4	Completed	Wannisa Suphachearabhan	108	2015-10-16 → 2019-03-02
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery NCT01010633	Phase 3	Completed	Bausch & Lomb Incorporated	406	2009-11 → 2010-08
Pediatric Zylet Safety and Efficacy Study NCT00420628	Phase 4	Completed	Bausch & Lomb Incorporated	108	2006-11 → 2009-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (1 brand, 2 generic)

Highest NADAC/Unit

$49.57

per gm

Lowest NADAC/Unit

$14.27

per gm

Brand NDCs

Generic NDCs

Avg Brand: $49.57

Avg Generic: $14.27

71% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24208050307LOTEMAX 0.5% OPHTHALMIC GEL	$49.57	GM	Brand	$14.27	2026-06-17
24208050801LOTEPREDNOL 0.5% OPHTHALMC GEL	$14.27	GM	Generic	—	2026-06-17
82260050801LOTEPREDNOL 0.5% OPHTHALMC GEL	$14.27	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$25.21

Highest Price

$154.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24208-0508-01LOTEPREDNOL ETABONATE 0.5% GEL,OPH	$70.35	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0508-01LOTEPREDNOL ETABONATE 0.5% GEL,OPH	$25.21	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0503-07LOTEMAX OPHTHALMIC GEL 0.5%	$154.14	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0503-07LOTEMAX OPHTHALMIC GEL 0.5%	$154.14	Big4	Bausch & Lomb Americas Inc.	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

ZACH SYSTEM SALOTEPREDNOL ETABONATE

DMF 111051994

INDUSTRIALE CHIMICA SRLLOTEPREDNOL ETABONATE

DMF 236722010

AARTI PHARMALABS LTDLOTEPREDNOL ETABONATE

DMF 262492012

FARMABIOS SPALOTEPREDNOL ETABONATE

DMF 269372013

FARMABIOS SPALOTEPREDNOL ETABONATE STERILE MICRONIZED

DMF 277172013

CURIA SPAIN SAULOTEPREDNOL ETABONATE STERILE MICRONIZED

DMF 280312014

SUN PHARMACEUTICAL INDUSTRIES LTDLOTEPREDNOL ETABONATE

DMF 323522018

CHEMO IBERICA SALOTEPREDNOL ETABONATE MICRONIZED STERILE

DMF 388172024

ALP PHARM BEIJING CO LTDInactiveLOTEPREDNOL ETABONATE

DMF 222782008

RELIANCE LIFE SCIENCES PVT LTDInactiveLOTEPREDNOL ETABONATE

DMF 254352011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 23, 2018	SUPPL -2	View Letter (PDF)
Oct 3, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLDAB

0 patents0 exclusivities▴

GEL;OPHTHALMIC | Approved: Sep 28, 2012

No patent or exclusivity listings for this strength.