LOTEPREDNOL ETABONATE - Generic Drug Details

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What are the generic drug sources for loteprednol etabonate and what is the scope of freedom to operate?

Loteprednol etabonate is the generic ingredient in seven branded drugs marketed by Bausch And Lomb Inc, Hikma, Sentiss, Sun Pharm, Bausch And Lomb, Alcon Labs Inc, Pharmos, Lupin Ltd, and Padagis Us, and is included in eighteen NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loteprednol etabonate has one hundred and fourteen patent family members in sixteen countries.

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

Summary for LOTEPREDNOL ETABONATE

International Patents:	114
US Patents:	21
Tradenames:	7
Applicants:	9
NDAs:	18
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	47
Patent Applications:	5,966
Drug Prices:	Drug price trends for LOTEPREDNOL ETABONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOTEPREDNOL ETABONATE
What excipients (inactive ingredients) are in LOTEPREDNOL ETABONATE?	LOTEPREDNOL ETABONATE excipients list
DailyMed Link:	LOTEPREDNOL ETABONATE at DailyMed

See drug prices for LOTEPREDNOL ETABONATE

Recent Clinical Trials for LOTEPREDNOL ETABONATE

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

Sponsor	Phase
Price Vision Group	Phase 4
Kala Pharmaceuticals, Inc.	Phase 4
Thomas Chester, OD	Phase 4

See all LOTEPREDNOL ETABONATE clinical trials

Pharmacology for LOTEPREDNOL ETABONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for LOTEPREDNOL ETABONATE

Anti-Allergic Agents

Anatomical Therapeutic Chemical (ATC) Classes for LOTEPREDNOL ETABONATE

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LOTEPREDNOL ETABONATE

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 LOTEPREDNOL ETABONATE

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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
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804-001	Dec 14, 2004		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alcon Labs Inc	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565-001	Aug 22, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	⤷ Sign Up	⤷ Sign Up
Pharmos	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020841-001	Mar 9, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LOTEPREDNOL ETABONATE

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1208161	顯示提高的粘膜轉移的藥物納米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)	⤷ Sign Up
Chile	2019003433		⤷ Sign Up
Chile	2014002956	Composicion farmaceutica ocular que comprende particulas recubiertas de dimension menor a 1 micron, con un nucleo que comprende etaboato de loteprednol y un recubrimiento con modificadores de superficie; y uso para tratar la inflamacion, degeneracion macular, edema macular u otro trastorno del ojo.	⤷ Sign Up
Brazil	112014027296		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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