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Last Updated: July 25, 2024

LIFITEGRAST - Generic Drug Details


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What are the generic sources for lifitegrast and what is the scope of patent protection?

Lifitegrast is the generic ingredient in two branded drugs marketed by Eugia Pharma, Micro Labs, and Bausch And Lomb Inc, and is included in three 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 are two tentative approvals 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;OPHTHALMIC
⤷  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 ⤷  Sign Up
Bausch And Lomb Inc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 AB RX Yes Yes ⤷  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
Micro Labs LIFITEGRAST lifitegrast SOLUTION/DROPS;OPHTHALMIC 215081-001 Aug 4, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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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