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

Brand (NDA) products

Originator applications

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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

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

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

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

Generic (ANDA) products (12)

Abbreviated applications

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LATANOPROST
MANKIND PHARMAANDA 2203602025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.005% SOLUTION/DROPS OPHTHALMIC Discontinued -
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
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
J MOLNERANDA 2009252011
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

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

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

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

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

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

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

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

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

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

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

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

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

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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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	U-2400
9629852	Sep 12, 2029	in 2 yr 11 mo	Product
8637054	Jul 08, 2031	in 4 yr 9 mo	ProductU-446

Approval history

FDA approval span

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First approval

Jun 05, 1996

30 yr 10 mo ago

Most recent approval

Dec 17, 2025

10 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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