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Last Updated: October 2, 2023

Lifitegrast - Generic Drug Details


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What are the generic drug sources for lifitegrast and what is the scope of freedom to operate?

Lifitegrast is the generic ingredient in two branded drugs marketed by Micro Labs and Novartis, and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lifitegrast has one hundred and fifty-four patent family members in twenty-five countries.

One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for lifitegrast
Recent Clinical Trials for lifitegrast

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

SponsorPhase
Novartis PharmaceuticalsPhase 4
State University of New York College of OptometryPhase 4
University of WaterlooPhase 4

See all lifitegrast clinical trials

Generic filers with tentative approvals for LIFITEGRAST
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5%SOLUTION;OPHTHALMIC
⤷  Try a Trial⤷  Try a Trial5%SOLUTION/DROPS;OPHTHALMIC
⤷  Try a Trial⤷  Try a Trial5%SOLUTION/DROPS;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for lifitegrast
Paragraph IV (Patent) Challenges for LIFITEGRAST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XIIDRA Ophthalmic Solution lifitegrast 5% 208073 4 2020-07-13

US Patents and Regulatory Information for lifitegrast

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for lifitegrast

Country Patent Number Title Estimated Expiration
Canada 2958665 COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY) ⤷  Try a Trial
Japan 2019081785 眼障害の治療のための組成物および方法 (COMPOSITIONS AND METHODS FOR TREATMENT OF EYE DISORDERS) ⤷  Try a Trial
European Patent Office 2934510 FORMULATIONS D'INHIBITEUR DE LFA-1 (LFA-1 INHIBITOR FORMULATIONS) ⤷  Try a Trial
Spain 2614080 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lifitegrast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2444079 C02444079/01 Switzerland ⤷  Try a Trial PRODUCT NAME: LIFITEGRAST; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66850 19.12.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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