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ETOPOPHOS PRESERVATIVE FREE

NDA

ETOPOSIDE PHOSPHATE | N020906 | BRISTOL MYERS SQUIBB

2 strengths0 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 Etopophos (2023)

Total Spending

$461K

Total Claims

34,704

Beneficiaries

3,826

ASP Price

—

HCPCS: J9181 — Injection, etoposide, 10 mg

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

API Supply Chain1 active DMF

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

NIPPON KAYAKU CO LTDETOPOSIDE PHOSPHATE

DMF 104761993

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2002	SUPPL -2	View Letter (PDF)
Feb 27, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 27, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 27, 1998