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Last Updated: December 8, 2022

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, Akorn, Bausch And Lomb, Alcon Labs Inc, Pharmos, and Sun Pharm, and is included in twelve NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loteprednol etabonate has ninety-eight patent family members in sixteen countries.

There are ten drug master file entries for loteprednol etabonate. Four 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
Price Vision GroupPhase 4
Kala Pharmaceuticals, Inc.Phase 4
Thomas Chester, ODPhase 4

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
Alcon Labs Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 212450-001 Feb 26, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 207609-001 Apr 17, 2019 AB RX No No See Plans and Pricing See Plans and Pricing 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 Y See Plans and Pricing
Alcon Labs Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

Expired US Patents for loteprednol etabonate

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

International Patents for loteprednol etabonate

Country Patent Number Title Estimated Expiration
China 107427464 眼用悬浮液组合物 (Ophthalmic suspension composition) See Plans and Pricing
Spain 2787039 See Plans and Pricing
Brazil 112014027296 nanopartículas farmacêuticas mostrando transporte mucosal melhorado See Plans and Pricing
European Patent Office 3808339 NANOPARTICLES PHARMACEUTIQUES MONTRANT DU TRANSPORT MUCOSALE AMÉLIORÉ (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT) See Plans and Pricing
Japan 2015515990 改善された粘膜輸送を示す医薬用ナノ粒子 See Plans and Pricing
New Zealand 728721 Pharmaceutical nanoparticles showing improved mucosal transport See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.