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Last Updated: May 19, 2022

LOTEMAX SM Drug Patent Profile


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When do Lotemax Sm patents expire, and what generic alternatives are available?

Lotemax Sm is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There is one patent protecting this drug.

This drug has eighteen patent family members in twelve countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Lotemax Sm

A generic version of LOTEMAX SM was approved as loteprednol etabonate by AKORN on April 17th, 2019.

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Drug patent expirations by year for LOTEMAX SM
Drug Prices for LOTEMAX SM

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Recent Clinical Trials for LOTEMAX SM

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

SponsorPhase
Thomas Chester, ODPhase 4
Illinois College of OptometryEarly Phase 1
Dr Salouti Eye Research CenterPhase 4

See all LOTEMAX SM clinical trials

Pharmacology for LOTEMAX SM
Anatomical Therapeutic Chemical (ATC) Classes for LOTEMAX SM

US Patents and Regulatory Information for LOTEMAX SM

LOTEMAX SM is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting LOTEMAX SM

Ophthalmic suspension composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY

FDA Regulatory Exclusivity protecting LOTEMAX SM

NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch And Lomb Inc LOTEMAX SM loteprednol etabonate GEL;OPHTHALMIC 208219-001 Feb 22, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Dow
Express Scripts
Johnson and Johnson
McKesson

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