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Last Updated: December 13, 2024

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 Eugia Pharma, Ingenus Pharms Llc, Micro Labs, and Bausch And Lomb Inc, and is included in four 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.

Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for lifitegrast
Recent Clinical Trials for lifitegrast

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

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

See all lifitegrast clinical trials

Generic filers with tentative approvals for LIFITEGRAST
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5%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
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Micro Labs LIFITEGRAST lifitegrast SOLUTION/DROPS;OPHTHALMIC 215081-001 Aug 4, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y 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 lifitegrast

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lifitegrast

Country Patent Number Title Estimated Expiration
European Patent Office 3195861 COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT DES TROUBLES DE LA SÈCHERESSE DE L' IL (COMPOSITIONS AND METHODS FOR TREATMENT OF DRY EYE DISORDERS) ⤷  Sign Up
Spain 2763703 ⤷  Sign Up
Australia 2019210525 LFA-1 inhibitor and polymorph thereof ⤷  Sign Up
European Patent Office 1682537 MODULATORS OF CELLULAR ADHESION ⤷  Sign Up
European Patent Office 3715345 PROCÉDÉ DE PRÉPARATION D'UN INHIBITEUR DE LFA-1 ET POLYMORPHE ASSOCIÉ (PREPARATION OF LFA-1 INHIBITOR AND POLYMORPH THEREOF) ⤷  Sign Up
Canada 2958665 COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY) ⤷  Sign Up
>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 ⤷  Sign Up 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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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.