Is there a generic for Latanoprost?

Yes. The FDA Orange Book lists 12 approved generic (ANDA) applications for Latanoprost, referencing the brand IYUZEH. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Latanoprost?

IYUZEH (NDA 216472, THEA PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Latanoprost?

The Orange Book lists 3 patents against Latanoprost products, with the earliest listed expiry in 2028. 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 Latanoprost are approved?

Latanoprost is approved in the following dosage forms: emulsion, solution/drops.

FDA Orange Book · active-ingredient family

Latanoprost

Latanoprost: 3 brands, 12 generics; first approved Jun 05, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 12 ANDA applications approved.

Earliest patent expiry Oct 15, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 15, 2028

in 2 yr 4 mo

Originator applications

Brand (NDA) products

IYUZEHRLDRS

THEA PHARMANDA 2164722022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	—

XELPROSRLD

SUN PHARMNDA 2061852018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	EMULSION	OPHTHALMIC	Discontinued	—

XALATANRLDRS

UPJOHNNDA 0205971996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Abbreviated applications

Generic (ANDA) products (12)

LATANOPROST

MANKIND PHARMAANDA 2203602025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

MICRO LABSANDA 2193062025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

GLANDANDA 2182572024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

EUGIA PHARMAANDA 2065192019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

LATANOPROST

FDC LTDANDA 2024422016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

CARNEGIEANDA 2020772013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

LATANOPROST

EPIC PHARMA LLCANDA 0908872011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

LATANOPROST

AMRING PHARMSANDA 2009252011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

APOTEX INCANDA 0776972011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

LATANOPROST

BAUSCH AND LOMBANDA 2010062011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

SANDOZANDA 0914492011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

LATANOPROST

SOMERSETANDA 2017862011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.005%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9539262	Oct 15, 2028	in 2 yr 4 mo	U-2400
9629852	Sep 12, 2029	in 3 yr 3 mo	Product
8637054	Jul 08, 2031	in 5 yr 1 mo	ProductU-446

FDA approval span

Approval history

First approval

Jun 05, 1996

30 yr 6 mo ago

Most recent approval

Dec 17, 2025

7 mo ago

Approvals span 1996–2025 across 15 FDA applications.

Brand (NDA) 320%

Generic (ANDA) 1280%

Latanoprost — 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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