Viewing data from:

VISUDYNE

NDA

VERTEPORFIN | N021119 | BAUSCH AND LOMB IRELAND LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Visudyne (2023)

Total Spending

$1.7M

Total Claims

1,220

Beneficiaries

937

ASP Price

—

HCPCS: J3396 — Injection, verteporfin, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALP PHARM BEIJING CO LTDInactiveVERTEPORFIN

DMF 243772010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 15MG/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 12, 2000

No patent or exclusivity listings for this strength.