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ETOPOPHOS PRESERVATIVE FREE

NDA

ETOPOSIDE PHOSPHATE | N020457 | CHEPLAPHARM ARZNEIMITTEL GMBH

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

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer NCT07057791	Phase 2	Recruiting	PrECOG, LLC.	60	2026-03-30 → 2030-01
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer NCT07149363	Phase 2	Recruiting	Alliance Foundation Trials, LLC.	65	2026-02-12 → 2031-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Etopophos (2023)

Total Spending

$11K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$109.44

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 100MG BASE/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 17, 1996

No patent or exclusivity listings for this strength.