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Last Updated: March 19, 2024

Topotecan hydrochloride - Generic Drug Details


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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 Sandoz, Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Sandoz Inc, Dash Pharms, and Hospira Inc, 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 eight drug master file entries for topotecan hydrochloride. Six 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: 8
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 108
Clinical Trials: 434
Patent Applications: 7,232
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
AmgenPhase 3
Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePhase 2
Bristol-Myers SquibbPhase 2

See all topotecan hydrochloride clinical trials

Pharmacology for topotecan hydrochloride
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase Inhibitors
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
Mylan Labs Ltd TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091542-001 Aug 28, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 201166-001 Aug 8, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira Inc TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 200582-001 Feb 2, 2011 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091376-001 Nov 29, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 206962-001 Nov 30, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for topotecan hydrochloride

Country Patent Number Title Estimated Expiration
Israel 175369 TOPOTECAN MONOHYDROCHLORIDE PENTAHYDRATE PRODUCTS, PROCESSES FOR MAKING THEM, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS FOR THERAPY ⤷  Try a Trial
European Patent Office 1689400 NOUVEAU COMPOSE, COMPOSITIONS CORRESPONDANTES, METHODES DE FABRICATION ET/OU DE TRAITEMENT (NOVEL COMPOUND, CORRESPONDING COMPOSITIONS, PREPARATION AND/OR TREATMENT METHODS) ⤷  Try a Trial
Iceland 8491 Nýtt efnasamband, samsvarandi blöndur, framleiðslu- og/eða meðhöndlunaraðferðir ⤷  Try a Trial
Australia 2004289318 Novel compound, corresponding compositions, preparation and/or treatment methods ⤷  Try a Trial
Taiwan I333492 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for topotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0321122 97C0009 Belgium ⤷  Try a Trial PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
0321122 SPC/GB96/057 United Kingdom ⤷  Try a 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 2/1997 Austria ⤷  Try a 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 C970017 Netherlands ⤷  Try a 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

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