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Last Updated: March 29, 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, 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. Seven 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
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
Alcon Labs Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Alcon Labs Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
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
>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 ⤷  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
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998 ⤷  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

International Patents for loteprednol etabonate

Country Patent Number Title Estimated Expiration
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) ⤷  Try a Trial
China 104661647 Pharmaceutical nanoparticles showing improved mucosal transport ⤷  Try a Trial
Mexico 2014013315 NANOPARTICULAS FARMACEUTICAS QUE MUESTRAN LA MEJORA DEL TRANSPORTE DE LA MUCOSA. (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT.) ⤷  Try a Trial
Hong Kong 1208160 顯示提高的粘膜轉移的藥物納米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT) ⤷  Try a Trial
South Korea 20150004909 PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT ⤷  Try a Trial
Hong Kong 1208162 顯示提高的粘膜轉移的藥物納米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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