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Last Updated: November 30, 2022

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 one branded drug marketed by Novartis and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two 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
See Plans and PricingSee Plans and Pricing5%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.

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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Baxter
AstraZeneca
Express Scripts
Johnson and Johnson

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