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FDA Orange Book · active-ingredient family

Lifitegrast

Lifitegrast: 1 brand, 3 generics; first approved Jul 11, 2016; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 3 ANDA applications approved.

Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
11
Next patent expiry
May 17, 2026
5 mo ago

Brand (NDA) products

Originator applications
  • XIIDRARLDRS
    NDA 2080732016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5%SOLUTION/DROPSOPHTHALMICRx—

Generic (ANDA) products (3)

Abbreviated applications
  • LIFITEGRAST
    ANDA 2150582024
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5%SOLUTION/DROPSOPHTHALMICDiscontinued—
  • LIFITEGRAST
    ANDA 2150632023
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5%SOLUTION/DROPSOPHTHALMICDiscontinued—
  • LIFITEGRAST
    ANDA 2150812023
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5%SOLUTION/DROPSOPHTHALMICDiscontinued—

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayPatent 8592450: 2026-05-17Patent 8592450Patent 8084047: 2026-05-17Patent 8084047Patent 9447077: 2029-04-15Patent 9447077Patent 8367701: 2029-04-15Patent 8367701Patent 8168655: 2029-05-09Patent 8168655Patent 7314938: 2029-06-25Patent 7314938Patent 9890141: 2030-10-21Patent 9890141Patent 9353088: 2030-10-21Patent 9353088Patent 8927574: 2030-11-12Patent 8927574Patent 9085553: 2033-07-25Patent 9085553Patent 11058677: 2033-12-18Patent 11058677
Patent expiryExclusivity endToday

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
85924505 mo ago
U-1880
80840475 mo ago
SubstanceProduct
9447077in 2 yr 7 mo
U-1900
8367701in 2 yr 7 mo
ProductU-1880
8168655in 2 yr 7 mo
U-1880
7314938in 2 yr 9 mo
SubstanceProduct
9890141in 4 yr 1 mo
Substance
9353088in 4 yr 1 mo
Product
8927574in 4 yr 2 mo
Product
9085553in 6 yr 11 mo
Product
11058677in 7 yr 4 mo
Product

Approval history

FDA approval span
First approval
10 yr 5 mo ago
Most recent approval
2 yr 1 mo ago

Approvals span 2016–2024 across 4 FDA applications.

Brand (NDA) 125%
Generic (ANDA) 375%

Lifitegrast: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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