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Profile for Tradename: LOTEMAX

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Lotemax is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos. and is included in four NDAs. It is available from two suppliers. There is one patent protecting this drug.

This drug has ten patent family members in nine countries.

The generic ingredient in LOTEMAX is loteprednol etabonate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

Summary for Tradename: LOTEMAX

Patents:1
Applicants:3
NDAs:4
Suppliers / Packagers: see list9

Pharmacology for Tradename: LOTEMAX

Clinical Trials for: LOTEMAX

Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%
Status: Completed Condition: Dry Eyes

Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
Status: Active, not recruiting Condition: Meibomian Gland Dysfunction; Posterior Blepharitis

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Status: Completed Condition: Conjunctivitis

Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca
Status: Completed Condition: Keratoconjunctivitis Sicca

Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery
Status: Active, not recruiting Condition: Pseudophakia; Inflammation

Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye
Status: Completed Condition: Dry Eye

Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Status: Completed Condition: Inflammation; Pain; Cataract

Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax
Status: Completed Condition: Sjogren's Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb Inc
LOTEMAX
loteprednol etabonate
GEL;OPHTHALMIC202872-001Sep 28, 2012RXYes5,800,807<disabled>Y <disabled>
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 1998RXYes<disabled><disabled>
Bausch And Lomb Inc
LOTEMAX
loteprednol etabonate
GEL;OPHTHALMIC202872-001Sep 28, 2012RXYes<disabled><disabled>
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Expired Patents for Tradename: LOTEMAX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 19984,996,335*PED<disabled>
Pharmos
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020841-001Mar 9, 19985,540,930<disabled>
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 19985,540,930*PED<disabled>
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International Patent Family for Tradename: LOTEMAX

Country Document Number Publication Date
Australia6253398Aug 18, 1998
European Patent Office0969812Jan 12, 2000
Hong Kong1026363Jul 09, 2004
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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