Viewing data from:

LOTEMAX

NDA

LOTEPREDNOL ETABONATE | N020583 | 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease NCT07671222	Phase 2	Not Yet Recruiting	Instituto de Oftalmología Fundación Conde de Valenciana	38	2026-12 → 2028-03

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

Medicare Part D Spending

CMS annual spending data for Lotemax (2023)

Total Spending

$10.8M

Total Claims

28,480

Beneficiaries

15,993

Avg Cost/Unit

$87.24

Spending Trend

$74.3M(2019)→$32.9M(2020)→$18.0M(2021)→$12.2M(2022)→$10.8M(2023)

YoY Change:+13.1%

5yr CAGR:+17.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 9, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLDAB

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Mar 9, 1998

No patent or exclusivity listings for this strength.