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Last Updated: March 19, 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, Sentiss, Slayback Pharma Llc, Sun Pharm, Bausch And Lomb, Alcon Labs Inc, Pharmos, and Lupin Ltd, and is included in sixteen 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 eleven patent family members in sixteen countries.

There are ten drug master file entries for loteprednol etabonate. Six 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
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
Lupin Ltd LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 215550-001 Dec 26, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon Labs Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon Labs Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb Inc LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872-001 Sep 28, 2012 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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