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Last Updated: November 2, 2024

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.

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
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
Alcon Labs Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alcon Labs Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 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

Expired US Patents for LOTEPREDNOL ETABONATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872-001 Sep 28, 2012 ⤷  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

Country Patent Number Title Estimated Expiration
Japan 7368661 ⤷  Sign Up
South Korea 20150006869 PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT ⤷  Sign Up
Japan 2021001187 複数の被覆された粒子を含む組成物、医薬組成物、医薬製剤、及び当該粒子の形成方法 (COMPOSITIONS COMPRISING MULTIPLE COATED PARTICLES, PHARMACEUTICAL COMPOSITIONS, PHARMACEUTICAL FORMULATIONS, AND METHODS OF FORMING THOSE PARTICLES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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