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EPIRUBICIN HYDROCHLORIDE

NDA

EPIRUBICIN HYDROCHLORIDE | N050807 | HOSPIRA INC

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
AAC Consulting Group - CP1 FDA-2006-P-0012 · 7 docket documents AAC Consulting Group, on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Epirubicin Hydrochloride Injection at 2 mg/mL in vial sizes of 10 mg/5mL, 20 mg/10mL, and 100 mg/50mL suitable for submission as an abbreviated new drug application, wi	Other	2008-08-13	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

287 trials from ClinicalTrials.gov — 6 recruiting, 18 active, 160 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer NCT04290793	Phase 2/3	Active	Hebei Medical University Fourth Hospital	113	2020-03-01 → 2026-12-10
TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature NCT02641847	Phase 2/3	Active	Fudan University	503	2016-01 → 2027-12
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 NCT03286634	Phase 2	Active	National Hospital Organization Nagoya Medical Center	60	2017-04-18 → 2033-03-31
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer NCT02299999	Phase 2	Active	UNICANCER	1,460	2014-04-07 → 2025-12
Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)NCT04296175	Phase 3	Active	Fudan University	808	2020-03-05 → 2027-03
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma NCT00005584	Phase 3	Active	European Organisation for Research and Treatment of Cancer - EORTC	1,649	1998-10
Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer NCT04193059	Phase 3	Active	Fudan University	1,560	2019-12-20 → 2027-07
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)NCT03725059	Phase 3	Active	Merck Sharp & Dohme LLC	1,240	2018-12-27 → 2031-01-24
PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial NCT02624973	Phase 2	Active	Haukeland University Hospital	200	2016-04-15 → 2030-06
Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients NCT00798070	Phase 3	Active	Karolinska University Hospital	2,017	2007-02 → 2028-01

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

API Supply Chain7 active DMFs3 inactive

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

SYNBIAS PHARMA AGEPIRUBICIN HYDROCHLORIDE

DMF 162582002

TAPI NL BVEPIRUBICIN HYDROCHLORIDE LYOPHILIZED

DMF 183072005

SHANDONG NEW TIME PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 198182006

TAPI NL BVEPIRUBICIN HYDROCHLORIDE PRECIPITATED

DMF 213032008

MICROBIOPHARM JAPAN CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 220182008

DZD (HEZE) PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE

DMF 313732017

SHANDONG NEW TIME PHARMACEUTICAL CO LTDEPIRUBICIN HYDROCHLORIDE USP

DMF 380602023

FARMITALIA CARLO ERBA SPAInactiveEPIRUBICIN HYDROCHLORIDE

DMF 53591984

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveEPIRUBICIN HYDROCHLORIDE

DMF 163242002

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveEPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 184982005

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 15, 2006

No patent or exclusivity listings for this strength.

#002 — 200MG/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Sep 15, 2006