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Last Updated: November 21, 2024

Loteprednol etabonate - Generic Drug Details


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What are the generic sources for loteprednol etabonate and what is the scope of patent protection?

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.

Drug Prices for loteprednol etabonate

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Recent Clinical Trials for loteprednol etabonate

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

SponsorPhase
Kala Pharmaceuticals, Inc.Phase 4
Price Vision GroupPhase 4
Thomas Chester, ODPhase 4

See all loteprednol etabonate clinical trials

Pharmacology for loteprednol etabonate
Medical Subject Heading (MeSH) Categories for loteprednol etabonate
Anatomical Therapeutic Chemical (ATC) Classes for loteprednol etabonate
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

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
Sentiss LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 215933-001 Apr 12, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Us LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 215203-001 Jul 10, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sentiss LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 207609-001 Apr 17, 2019 AB RX No No ⤷  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

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

International Patents for loteprednol etabonate

Country Patent Number Title Estimated Expiration
South Korea 20150006869 PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT ⤷  Sign Up
Japan 2022009979 医薬組成物 ⤷  Sign Up
European Patent Office 4008355 NANOPARTICULES PHARMACEUTIQUES PERMETTANT UN TRANSPORT MUQUEUX AMÉLIORÉ (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT) ⤷  Sign Up
Hong Kong 1208382 顯示提高的粘膜轉移的藥物納米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT) ⤷  Sign Up
Mexico 2020007227 NANOPARTICULAS FARMACEUTICAS QUE MUESTRAN LA MEJORA DEL TRANSPORTE DE LA MUCOSA. (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT.) ⤷  Sign Up
>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.