➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Mallinckrodt
Express Scripts
Johnson and Johnson
Merck

Last Updated: July 28, 2021

DrugPatentWatch Database Preview

Topotecan hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic drug sources for topotecan hydrochloride and what is the scope of freedom to operate?

Topotecan hydrochloride is the generic ingredient in three branded drugs marketed by Novartis, Accord Hlthcare, Actavis Totowa, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms, Sun Pharm Inds Ltd, Sandoz Inc, Hospira Inc, and Teva Pharms Usa, and is included in eighteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Topotecan hydrochloride has eighteen patent family members in sixteen countries.

There are ten drug master file entries for topotecan hydrochloride. Eleven suppliers are listed for this compound.

Summary for topotecan hydrochloride
International Patents:18
US Patents:1
Tradenames:3
Applicants:14
NDAs:18
Drug Master File Entries: 10
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 99
Clinical Trials: 392
Patent Applications: 7,685
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in topotecan hydrochloride?topotecan hydrochloride excipients list
DailyMed Link:topotecan hydrochloride at DailyMed
Recent Clinical Trials for topotecan hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jiangsu Simcere Pharmaceutical Co., Ltd.Phase 3
Merck KGaA, Darmstadt, GermanyPhase 2
EMD Serono Research & Development Institute, Inc.Phase 2

See all topotecan hydrochloride clinical trials

Pharmacology for topotecan hydrochloride
Medical Subject Heading (MeSH) Categories for topotecan hydrochloride

US Patents and Regulatory Information for topotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 202203-001 Aug 29, 2013 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sandoz Inc TOPOTECAN topotecan hydrochloride SOLUTION;INTRAVENOUS 200199-001 Feb 25, 2011 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 202351-001 Jun 26, 2013 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for topotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for topotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0321122 2/1997 Austria ⤷  Free Forever Trial PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
0321122 SPC/GB96/057 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
0321122 C970017 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Mallinckrodt
Express Scripts
Johnson and Johnson
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.