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Boehringer Ingelheim

Last Updated: May 29, 2023

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 and one Paragraph IV challenge.

This drug has twenty-three patent family members in thirteen countries.

The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten drug master file entries for this compound. Five 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

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

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Pharmacology for LOTEMAX SM
Anatomical Therapeutic Chemical (ATC) Classes for LOTEMAX SM
Paragraph IV (Patent) Challenges for LOTEMAX SM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOTEMAX SM Ophthalmic Gel loteprednol etabonate 0.38% 208219 1 2022-11-14

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting LOTEMAX SM

Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for LOTEMAX SM

See the table below for patents covering LOTEMAX SM around the world.

Country Patent Number Title Estimated Expiration
Spain 2924645 ⤷  Try a Trial
Brazil 112017016016 composição de suspensão oftálmica ⤷  Try a Trial
Poland 3721868 ⤷  Try a Trial
Poland 3470059 ⤷  Try a Trial
Australia 2016211745 Ophthalmic suspension composition ⤷  Try a Trial
Portugal 3721868 ⤷  Try a Trial
South Korea 20170105610 안과용 현탁액 조성물 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.