Is there a generic for Loteprednol etabonate?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Loteprednol etabonate, referencing the brand EYSUVIS. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Loteprednol etabonate?

EYSUVIS (NDA 210933, ALCON LABS INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Loteprednol etabonate?

The Orange Book lists 23 patents against Loteprednol etabonate products, with the earliest listed expiry in 2033. 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 Loteprednol etabonate are approved?

Loteprednol etabonate is approved in the following dosage forms: gel, ointment, suspension/drops.

FDA Orange Book · active-ingredient family

Loteprednol etabonate

Loteprednol etabonate: 8 brands, 13 generics; first approved Mar 09, 1998; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 13 ANDA applications approved.

Earliest patent expiry May 03, 2033

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 03, 2033

in 6 yr 7 mo

Brand (NDA) products

Originator applications

EYSUVISRLDRS
ALCON LABS INCNDA 2109332020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SUSPENSION/DROPS OPHTHALMIC Rx -
LOTEMAX SMRLDRS
BAUSCH AND LOMB INCNDA 2082192019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.38% GEL OPHTHALMIC Rx AB
INVELTYSRLDRS
ALCON LABS INCNDA 2105652018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SUSPENSION/DROPS OPHTHALMIC Rx -
LOTEMAXRLDRS
BAUSCH AND LOMB INCNDA 2028722012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% GEL OPHTHALMIC Rx AB
LOTEMAXRLDRS
BAUSCH AND LOMBNDA 2007382011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% OINTMENT OPHTHALMIC Rx -
ALREXRLDRS
BAUSCH AND LOMBNDA 0208031998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEMAXRLDRS
BAUSCH AND LOMBNDA 0205831998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEMAX
PHARMOSNDA 0208411998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SUSPENSION/DROPS	OPHTHALMIC	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.38%	GEL	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SUSPENSION/DROPS	OPHTHALMIC	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	GEL	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	OINTMENT	OPHTHALMIC	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Discontinued	-

Generic (ANDA) products (13)

Abbreviated applications

LOTEPREDNOL ETABONATE
LUPINANDA 2180872025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.38% GEL OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
AMNEALANDA 2174842025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
PADAGIS USANDA 2152042025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
AMNEALANDA 2163452024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
PADAGIS USANDA 2152032024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
LUPINANDA 2157192024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
LUPINANDA 2155502023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
HIKMAANDA 2139562023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% GEL OPHTHALMIC Discontinued -
LOTEPREDNOL ETABONATE
SUN PHARMANDA 2153842023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% GEL OPHTHALMIC Discontinued -
LOTEPREDNOL ETABONATE
SENTISSANDA 2159332023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
SUN PHARMANDA 2124502021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
SENTISSANDA 2120802021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% GEL OPHTHALMIC Rx AB
LOTEPREDNOL ETABONATE
SENTISSANDA 2076092019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SUSPENSION/DROPS OPHTHALMIC Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.38%	GEL	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	GEL	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	GEL	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	GEL	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SUSPENSION/DROPS	OPHTHALMIC	Rx	AB

Patent & exclusivity timeline

Protection horizon

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.
Patent	Expires	In	Type
11219596	May 03, 2033	in 6 yr 7 mo	U-2985
11596599	May 03, 2033	in 6 yr 7 mo	U-2985
10857096	May 03, 2033	in 6 yr 7 mo	U-2985
10945948	May 03, 2033	in 6 yr 7 mo	U-2985
10940108	May 03, 2033	in 6 yr 7 mo	U-2985
9532955	May 03, 2033	in 6 yr 7 mo	U-2491
9737491	May 03, 2033	in 6 yr 7 mo	U-2492
9056057	May 03, 2033	in 6 yr 7 mo	ProductU-2491
9827191	May 03, 2033	in 6 yr 7 mo	ProductU-2985
10058511	May 03, 2033	in 6 yr 7 mo	ProductU-2492
10993908	May 03, 2033	in 6 yr 7 mo	U-3117
12115246	May 03, 2033	in 6 yr 7 mo	ProductU-2985
11642317	May 03, 2033	in 6 yr 7 mo	Product
10688045	May 03, 2033	in 6 yr 7 mo	Product
10646436	May 03, 2033	in 6 yr 7 mo	Product
9393213	May 03, 2033	in 6 yr 7 mo	Product
11872318	May 03, 2033	in 6 yr 7 mo	Product
11219597	May 03, 2033	in 6 yr 7 mo	U-3278
10864219	May 03, 2033	in 6 yr 7 mo	U-3011
10646437	May 03, 2033	in 6 yr 7 mo	Product
11534395	Jan 26, 2036	in 9 yr 5 mo	ProductU-2764
12589069	Jan 26, 2036	in 9 yr 5 mo	ProductU-2764
10596107	Dec 23, 2036	in 10 yr 4 mo	ProductU-2764

Approval history

FDA approval span

First approval

Mar 09, 1998

29 yr 1 mo ago

Most recent approval

Jun 30, 2025

1 yr 4 mo ago

Approvals span 1998–2025 across 21 FDA applications.

Brand (NDA) 838%

Generic (ANDA) 1362%

Loteprednol etabonate: 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.

Ask AI about Loteprednol etabonate

Key facts

Active ingredient: Loteprednol etabonate
Brand (NDA): 8
Generic (ANDA): 13
Reference-listed drug: EYSUVIS
Dosage forms: GEL, OINTMENT, SUSPENSION/DROPS
Routes: OPHTHALMIC
TE codes: AB
Earliest patent expiry: May 03, 2033

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