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Details for Generic Name: loteprednol etabonate

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Loteprednol etabonate is the generic ingredient in three branded drugs marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has ten patent family members in nine countries.

There are nine drug master file entries for loteprednol etabonate. Three suppliers are listed for this compound.

Summary for Generic Name: loteprednol etabonate

Tradenames:3
Patents:1
Applicants:3
NDAs:6
Drug Master File Entries: see list9
Suppliers / Packaging: see list15
Therapeutic Class:Ophthalmic Agents

Pharmacology for Ingredient: loteprednol etabonate

Clinical Trials for: loteprednol etabonate

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

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

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Status: Completed Condition: Allergic Conjunctivitis

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

Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Status: Completed Condition: Ocular Inflammation

Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Status: Completed Condition: Inflammation; Pain

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

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
Status: Completed Condition: Allergic Conjunctivitis

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
Pharmos
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020841-001Mar 9, 1998DISCNNo<disabled><disabled>
Bausch And Lomb Inc
LOTEMAX
loteprednol etabonate
GEL;OPHTHALMIC202872-001Sep 28, 2012RXYes<disabled><disabled>
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 2004RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: loteprednol etabonate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
ALREX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020803-001Mar 9, 19984,996,335*PED<disabled>
Pharmos
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020841-001Mar 9, 19985,540,930<disabled>
Pharmos
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020841-001Mar 9, 19984,996,335<disabled>
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International Patent Family for Ingredient: loteprednol etabonate

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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Copyright 2002-2016 thinkBiotech LLC
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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