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CERUBIDINE

NDA

DAUNORUBICIN HYDROCHLORIDE | N050484 | WYETH AYERST RESEARCH

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

3 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy NCT05777317	N/A	Active	Nevro Corp	143	2023-04-24 → 2026-07
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation NCT07211958	Phase 3	Recruiting	Syndax Pharmaceuticals	468	2025-11-25 → 2031-01
Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia NCT04230239	Phase 2	Completed	PETHEMA Foundation	59	2019-12-26 → 2021-08-11

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

API Supply Chain7 active DMFs3 inactive

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

MICROBIOPHARM JAPAN CO LTDDAUNORUBICIN HYDROCHLORIDE (CRUDE)

DMF 118791996

MEIJI SEIKA PHARMA CO LTDDAUNORUBICIN HYDROCHLORIDE (DRUG SUBSTANCE)

DMF 137271998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDAUNORUBICIN HYDROCHLORIDE USP

DMF 137751998

TAPI NL BVDAUNORUBICIN HYDROCHLORIDE

DMF 137861998

OLON SPADAUNORUBICIN HYDROCHLORIDE

DMF 304252016

DZD (HEZE) PHARMACEUTICAL CO LTDDAUNORUBICIN HYDROCHLORIDE

DMF 311502016

SHANDONG NEW TIME PHARMACEUTICAL CO LTDDAUNORUBICIN HYDROCHLORIDE

DMF 386252023

HAIMEN PHARM FACTORYInactiveDAUNORUBICIN HYDROCHLORIDE

DMF 88291990

RHONE POULENC RORER PHARMACEUTICALS INCInactiveDAUNORUBICIN HYDROCHLORIDE

DMF 135031998

CHEMWERTH INCInactiveDAUNORUBICIN HYDROCHLORIDE (TECHNICAL GRADE)

DMF 172182004

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

Products (1)

#001 — EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.