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Loteprednol etabonate - Generic Drug Details

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Loteprednol etabonate is the generic ingredient in three branded drugs marketed by Bausch And Lomb, Pharmos, and Bausch And Lomb Inc, 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 list3
Therapeutic Class:Ophthalmic Agents

Pharmacology for Ingredient: loteprednol etabonate

Clinical Trials for: loteprednol etabonate

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, 2012RXYes<disabled><disabled>
Bausch And Lomb
ZYLET
loteprednol etabonate; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050804-001Dec 14, 2004RXYes<disabled><disabled>
Bausch And Lomb
LOTEMAX
loteprednol etabonate
OINTMENT;OPHTHALMIC200738-001Apr 15, 2011RXYes<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
Pharmos
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020841-001Mar 9, 19985,540,930<disabled>
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 19984,996,335*PED<disabled>
Bausch And Lomb
ALREX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020803-001Mar 9, 19985,540,930*PED<disabled>
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International Patent Family for Ingredient: loteprednol etabonate

Country Document Number Estimated Expiration
Hong Kong1026363<disabled in preview>
World Intellectual Property Organization (WIPO)9832421<disabled in preview>
Spain2205449<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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