Viewing data from:

HYCAMTIN

NDA

TOPOTECAN HYDROCHLORIDE | N020671 | SANDOZ INC

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

12 trials from ClinicalTrials.gov — 7 recruiting, 4 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
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
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
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy NCT05990738	Phase 1	Active	Boehringer Ingelheim	69	2024-02-14 → 2027-04-30
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy NCT06425419	Phase 1	Not Yet Recruiting	Massachusetts Eye and Ear Infirmary	50	2026-09-01 → 2028-09-01
A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer NCT07545460	Phase 3	Not Yet Recruiting	Sichuan Baili Pharmaceutical Co., Ltd.	404	2026-07 → 2028-12
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer NCT06801834	Phase 3	Recruiting	Gilead Sciences	695	2025-04-04 → 2029-10
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression NCT07214779	Phase 3	Recruiting	Incyte Corporation	466	2025-12-09 → 2029-05-14
A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression NCT07546500	Phase 3	Recruiting	K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc	420	2026-04-17 → 2030-04-30
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)NCT07218146	Phase 3	Recruiting	Zai Lab (Shanghai) Co., Ltd.	480	2025-11-30 → 2028-11-30

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

11 letters from Drugs@FDA

Date	Submission	Document
Oct 9, 2019	SUPPL -24	View Letter (PDF)
Sep 12, 2018	SUPPL -23	View Letter (PDF)
Jun 4, 2015	SUPPL -21	View Letter (PDF)
Mar 5, 2014	SUPPL -20	View Letter (PDF)
Apr 5, 2010	SUPPL -17	View Letter (PDF)
Apr 5, 2010	SUPPL -16	View Letter (PDF)
Jun 20, 2006	SUPPL -14	View Letter (PDF)
Jun 8, 2003	SUPPL -12	View Letter (PDF)
Mar 28, 2003	SUPPL -11	View Letter (PDF)
Mar 6, 2002	SUPPL -9	View Letter (PDF)
Nov 30, 1998	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 4MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 28, 1996

No patent or exclusivity listings for this strength.