FDA Orange Book

Is there a generic for Visudyne?

Visudyne contains verteporfin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Visudyne (verteporfin).

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Visudyne products in the Orange Book

Visudyne products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection15MG/VIALMarketed (Rx)None0None

NDA 021119, held by BAUSCH AND LOMB IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Visudyne NDC codes

Questions

Is there a generic for Visudyne?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Visudyne (verteporfin).

What is the generic name for Visudyne?

The active ingredient in Visudyne is verteporfin, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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