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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Johnson and Johnson
Fish and Richardson
Baxter
Teva
AstraZeneca
Julphar
McKinsey

Generated: October 17, 2018

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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 freedom to operate?

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.

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

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
Sagent Pharms TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091284-001 Jan 26, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 204406-002 Jul 6, 2017 AP RX No No ➤ 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
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 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for topotecan hydrochloride

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

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Johnson and Johnson
Fish and Richardson
Baxter
Teva
AstraZeneca
Julphar
McKinsey

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