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BLENOXANE

NDA

BLEOMYCIN SULFATE | N050443 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Self-controlled Study of Bleomycin and Pingyangmycin Injection in the Treatment of Plantar Warts NCT07197541	Phase 4	Active	Second Affiliated Hospital, School of Medicine, Zhejiang University	200	2025-10-01 → 2026-11-01

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

Medicare Part B Spending

CMS physician-administered drug spending for Bleo 15k (2023)

Total Spending

$64K

Total Claims

2,074

Beneficiaries

984

ASP Price

$24.66

YoY Change:-5.3%

5yr CAGR:-2.7%

HCPCS: J9040 — Injection, bleomycin sulfate, 15 units

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

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVBLEOMYCIN SULFATE

DMF 137841998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDBLEOMYCIN SULFATE USP (PROCESS II)

DMF 263122012

HUBEI HONCH PHARMACEUTICAL CO LTDBLEOMYCIN SULFATE

DMF 426292025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveBLEOMYCIN SULFATE USP

DMF 129621998

MAYNE PHARMA USA INCInactiveBLEOMYCIN SULFATE

DMF 132541998

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 17, 2010	SUPPL -36	View Letter (PDF)
Jul 1, 2004	SUPPL -27	View Letter (PDF)
Mar 26, 2003	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 7, 1995