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TOPOTECAN

NDA

TOPOTECAN HYDROCHLORIDE | N200199 | SANDOZ INC

3 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0271 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Topotecan Hydrochloride Intravenous Solution in three strengths (1 mg base/mL, 3 mg base/3 mL, and 4 mg base/4 mL) by Sandoz, Inc. under NDA 200-199 was voluntarily withdrawn from sale for safety or effec	505(q)	2012-03-26	Denied	—

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

Clinical Trials

308 trials from ClinicalTrials.gov — 3 recruiting, 10 active, 215 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors NCT02114229	Phase 2	Active	St. Jude Children's Research Hospital	125	2014-05-14 → 2027-09
Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer NCT01012817	Phase 1/2	Active	National Cancer Institute (NCI)	88	2009-11-03 → 2027-03-10
Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer NCT02502266	Phase 2/3	Active	National Cancer Institute (NCI)	582	2016-05-03 → 2027-03-04
Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma NCT01783535	Phase 2	Active	St. Jude Children's Research Hospital	174	2013-06-19 → 2027-02-21
Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma NCT02298348	Phase 1	Active	New Approaches to Neuroblastoma Therapy Consortium	18	2015-10-08 → 2026-12
A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma NCT04047251	Phase 1	Active	Fujifilm Pharmaceuticals U.S.A., Inc.	96	2019-11-14 → 2026-07
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma NCT04106219	Phase 1	Active	Eli Lilly and Company	71	2020-06-11 → 2026-08
Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs NCT03896503	Phase 2	Active	National Cancer Institute (NCI)	104	2019-12-30 → 2027-05-13
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia NCT03289910	Phase 2	Active	National Cancer Institute (NCI)	25	2018-09-24 → 2026-12-18
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors NCT03709680	Phase 2	Active	Pfizer	128	2019-05-24 → 2025-10-18

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

API Supply Chain3 active DMFs5 inactive

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

SCINOPHARM TAIWAN LTDTOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE

DMF 208102007

EMCURE PHARMACEUTICALS LTDTOPOTECAN HYDROCHLORIDE

DMF 234432010

NOVARTIS PHARMACEUTICALS CORPTOPOTECAN HYDROCHLORIDE

DMF 244582011

DR REDDYS LABORATORIES LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 198342006

SAI PHYTOCEUTICALS PVT LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 207232007

CIPLA LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 216212008

FRESENIUS KABI ONCOLOGY LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 223032009

SYNBIAS PHARMA LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 236822010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 5, 2014	SUPPL -3	View Letter (PDF)
Mar 2, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 25, 2011

No patent or exclusivity listings for this strength.

#002 — EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 25, 2011

#003 — EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 25, 2011