Is there a generic for Latanoprostene bunod?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Latanoprostene bunod, referencing the brand VYZULTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Latanoprostene bunod?

VYZULTA (NDA 207795, BAUSCH AND LOMB) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Latanoprostene bunod?

The Orange Book lists 1 patent against Latanoprostene bunod products, with the earliest listed expiry in 2029. 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 Latanoprostene bunod are approved?

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

FDA Orange Book · active-ingredient family

Latanoprostene bunod

Latanoprostene bunod: 1 brand, 1 generic; first approved Nov 02, 2017; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Feb 21, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 21, 2029

in 2 yr 4 mo

Brand (NDA) products

Originator applications

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VYZULTARLDRS
BAUSCH AND LOMBNDA 2077952017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.024% SOLUTION/DROPS OPHTHALMIC Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.024%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Generic (ANDA) products (1)

Abbreviated applications

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LATANOPROSTENE BUNOD
GLANDANDA 2173872025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.024% SOLUTION/DROPS OPHTHALMIC Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.024%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

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
8058467	Feb 21, 2029	in 2 yr 4 mo	SubstanceU-2144

Approval history

FDA approval span

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First approval

Nov 02, 2017

9 yr 1 mo ago

Most recent approval

Apr 29, 2025

1 yr 6 mo ago

Approvals span 2017–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Latanoprostene bunod: 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

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