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 are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty 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. Eight 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 SENTISS on April 17^th, 2019.

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Summary for LOTEMAX SM

International Patents:	30
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	22
Drug Prices:	Drug price information for LOTEMAX SM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOTEMAX SM
What excipients (inactive ingredients) are in LOTEMAX SM?	LOTEMAX SM excipients list
DailyMed Link:	LOTEMAX SM at DailyMed

Drug patent expirations by year for LOTEMAX SM

Recent Clinical Trials for LOTEMAX SM

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

Sponsor	Phase
Thomas Chester, OD	Phase 4
Illinois College of Optometry	Early Phase 1
Dr Salouti Eye Research Center	Phase 4

See all LOTEMAX SM clinical trials

Pharmacology for LOTEMAX SM

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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 two US patents.

Patents protecting LOTEMAX SM

Ophthalmic suspension composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219-001	Feb 22, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3721868	COMPOSITION DE SUSPENSION OPHTALMIQUE (OPHTHALMIC SUSPENSION COMPOSITION)	⤷ Sign Up
European Patent Office	4082531	COMPOSITION DE SUSPENSION OPHTALMIQUE (OPHTHALMIC SUSPENSION COMPOSITION)	⤷ Sign Up
Poland	3721868		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016123079		⤷ Sign Up
Hungary	E041945		⤷ Sign Up
Hungary	E066045		⤷ Sign Up
South Korea	20170105610	안과용 현탁액 조성물	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration