Viewing data from:

LOTEMAX SM

NDA

LOTEPREDNOL ETABONATE | N208219 | BAUSCH AND LOMB INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

2028

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2035

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2037

Today

10596107

Dec. 23, 2036

11534395

Jan. 26, 2036

12589069

Jan. 26, 2036

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
BAUSCH & LOMB INCORPORATED et al v. SANDOZ INC. 2:2025cv01167 2 patentsANDA 218526loteprednol etabonate	D.N.J.	2025-02-11	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lotemax Sm (2023)

Total Spending

$20.5M

Total Claims

75,703

Beneficiaries

43,117

Avg Cost/Unit

$50.88

Spending Trend

$7.0M(2019)→$13.4M(2020)→$19.8M(2021)→$22.3M(2022)→$20.5M(2023)

YoY Change:+6.4%

5yr CAGR:+6.6%

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 5, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.38%

RLDAB

3 patents0 exclusivities▴

GEL;OPHTHALMIC | Approved: Feb 22, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10596107	Dec 23, 2036	—	—	Yes	—
11534395	Jan 26, 2036	—	—	Yes	—
12589069	Jan 26, 2036	—	—	Yes	—

Change History (1)

Recent changes detected for this application.

MODIFIEDsubmission_date7/1/2026

Bausch and Lomb updated the submission date for U.S. Patent 12,589,069 listed for LOTEMAX SM (loteprednol etabonate) from May 7, 2026 to Apr 30, 2026 in the Orange Book.

Old: May 7, 2026

New: Apr 30, 2026