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Last Updated: July 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, Novast Labs, Rising, 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: 7,630
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
Verastem, Inc.Phase 3
GOG FoundationPhase 3
AmgenPhase 3

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
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 202351-001 Jun 26, 2013 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 022453-001 Dec 20, 2012 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira Inc TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 200582-001 Feb 2, 2011 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz Inc TOPOTECAN topotecan hydrochloride SOLUTION;INTRAVENOUS 200199-001 Feb 25, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Sign Up ⤷  Sign Up
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Sign Up ⤷  Sign Up
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for topotecan hydrochloride

Country Patent Number Title Estimated Expiration
Brazil PI0416366 composto, composições correspondentes, métodos de preparação e/ou de tratamento ⤷  Sign Up
South Africa 200603508 Novel compound, corresponding compositions, preparation and/or treatment methods ⤷  Sign Up
Norway 20062616 ⤷  Sign Up
China 1913897 Novel compound, corresponding compositions, preparation and/or treatment methods ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for topotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0321122 2/1997 Austria ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  Sign Up 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
0321122 97C0009 Belgium ⤷  Sign Up PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.