Is there a generic for Lifitegrast?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Lifitegrast, referencing the brand XIIDRA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lifitegrast?

XIIDRA (NDA 208073, BAUSCH AND LOMB INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Lifitegrast?

The Orange Book lists 11 patents against Lifitegrast products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Lifitegrast are approved?

Lifitegrast is approved in the following dosage form: solution/drops.

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 May 17, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 17, 2026

5 mo ago

Brand (NDA) products

Originator applications

Ask AI

XIIDRARLDRS
BAUSCH AND LOMB INCNDA 2080732016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION/DROPS OPHTHALMIC Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION/DROPS	OPHTHALMIC	Rx	-

Generic (ANDA) products (3)

Abbreviated applications

Ask AI

LIFITEGRAST
INGENUS PHARMS LLCANDA 2150582024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION/DROPS OPHTHALMIC Discontinued -
LIFITEGRAST
EUGIA PHARMAANDA 2150632023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION/DROPS OPHTHALMIC Discontinued -
LIFITEGRAST
MICRO LABSANDA 2150812023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION/DROPS OPHTHALMIC Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Patent & exclusivity timeline

Protection horizon

Ask AI

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Ask AI

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8592450	May 17, 2026	5 mo ago	U-1880
8084047	May 17, 2026	5 mo ago	SubstanceProduct
9447077	Apr 15, 2029	in 2 yr 6 mo	U-1900
8367701	Apr 15, 2029	in 2 yr 6 mo	ProductU-1880
8168655	May 09, 2029	in 2 yr 7 mo	U-1880
7314938	Jun 25, 2029	in 2 yr 9 mo	SubstanceProduct
9890141	Oct 21, 2030	in 4 yr 1 mo	Substance
9353088	Oct 21, 2030	in 4 yr 1 mo	Product
8927574	Nov 12, 2030	in 4 yr 1 mo	Product
9085553	Jul 25, 2033	in 6 yr 10 mo	Product
11058677	Dec 18, 2033	in 7 yr 3 mo	Product

Approval history

FDA approval span

Ask AI

First approval

Jul 11, 2016

10 yr 5 mo ago

Most recent approval

Oct 03, 2024

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.

Related FDA reference tools

Assyro Intelligence

Ask anything about Lifitegrast

Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.

Evaluating for a team? Book a demo