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Last Updated: February 25, 2021

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Loteprednol etabonate - Generic Drug Details

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What are the generic sources for loteprednol etabonate and what is the scope of patent protection?

Loteprednol etabonate is the generic ingredient in seven branded drugs marketed by Bausch And Lomb Inc, Bausch And Lomb, Kala Pharms Inc, Pharmos, and Akorn, and is included in ten NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loteprednol etabonate has eighty-five patent family members in fifteen countries.

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

Drug Prices for loteprednol etabonate

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Recent Clinical Trials for loteprednol etabonate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Thomas Chester, ODPhase 4
Illinois College of OptometryEarly Phase 1
SandozPhase 1

See all loteprednol etabonate clinical trials

Pharmacology for loteprednol etabonate
Medical Subject Heading (MeSH) Categories for loteprednol etabonate

US Patents and Regulatory Information for loteprednol etabonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kala Pharms Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kala Pharms Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Kala Pharms Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kala Pharms Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kala Pharms Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for loteprednol etabonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872-001 Sep 28, 2012   Start Trial   Start Trial
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998   Start Trial   Start Trial
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998   Start Trial   Start Trial
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998   Start Trial   Start Trial
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998   Start Trial   Start Trial
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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