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Last Updated: July 4, 2020

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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 six branded drugs marketed by Bausch And Lomb Inc, Bausch And Lomb, Kala Pharms Inc, Pharmos, and Hi Tech, and is included in nine NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loteprednol etabonate has sixty-six 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
SandozPhase 1
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPhase 4
Valeant Pharmaceuticals International, Inc.Phase 3

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
Bausch And Lomb Inc LOTEMAX SM loteprednol etabonate GEL;OPHTHALMIC 208219-001 Feb 22, 2019 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
>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 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
Bausch And Lomb Inc LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872-001 Sep 28, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Dow
AstraZeneca
McKinsey
Harvard Business School
Moodys

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