Question 1

Is there a generic for Latanoprostene bunod?

Accepted Answer

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.

Question 2

What is the reference-listed drug for Latanoprostene bunod?

Accepted Answer

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.

Question 3

What patents protect Latanoprostene bunod?

Accepted Answer

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.

Question 4

What dosage forms of Latanoprostene bunod are approved?

Accepted Answer

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

Latanoprostene bunod

Brand (NDA) products · solution/drops

Generic (ANDA) products (1)

Listed patents (1)

Latanoprostene bunod — frequently asked questions

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