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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Cerilliant
Johnson and Johnson
Baxter
McKinsey
Fish and Richardson
Mallinckrodt
Fuji

Generated: August 14, 2018

DrugPatentWatch Database Preview

Topotecan hydrochloride - Generic Drug Details

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What are the generic drug sources for topotecan hydrochloride and what is the scope of topotecan hydrochloride patent protection?

Topotecan hydrochloride is the generic ingredient in three branded drugs marketed by Novartis Pharms Corp, Accord Hlthcare, Actavis Totowa, Cipla Ltd, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hong Kong, Mylan Labs Ltd, Novast Labs Ltd, 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
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
Hospira Inc TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 200582-001 Feb 2, 2011 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dr Reddys Labs Ltd TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 201191-001 Mar 9, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 202351-001 Jun 26, 2013 AP RX No 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

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Expired US Patents for topotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for topotecan hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,754,733 Crystalline topotecan hydrochloride product and process for making the same ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for topotecan hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 Belgium ➤ Sign Up PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
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
C/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
70017 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
McKinsey
Chubb
Fish and Richardson
Harvard Business School
AstraZeneca
Baxter
Johnson and Johnson
Federal Trade Commission

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 verifification 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.