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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	438
Patent Applications:	7,682
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

Sponsor	Phase
Verastem, Inc.	Phase 3
GOG Foundation	Phase 3
Luye Pharma Group Ltd.	Phase 3

See all topotecan hydrochloride clinical trials

Pharmacology for topotecan hydrochloride

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for topotecan hydrochloride

Topoisomerase I Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for topotecan hydrochloride

L01CE	Topoisomerase 1 (TOP1) inhibitors
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for topotecan hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	091542-001	Aug 28, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz Inc	TOPOTECAN	topotecan hydrochloride	SOLUTION;INTRAVENOUS	200199-003	Feb 25, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	SOLUTION;INTRAVENOUS	204406-001	Jul 6, 2017		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

Expired US Patents for topotecan hydrochloride

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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

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Country	Patent Number	Title	Estimated Expiration
Iceland	8491	Nýtt efnasamband, samsvarandi blöndur, framleiðslu- og/eða meðhöndlunaraðferðir	⤷ Sign Up
Russian Federation	2352572	ПЕНТАГИДРАТ МОНОГИДРОХЛОРИДА ТОПОТЕКАНА В КРИСТАЛЛИЧЕСКОЙ ФОРМЕ, СООТВЕТСТВУЮЩИЕ КОМПОЗИЦИИ НА ИХ ОСНОВЕ, СПОСОБЫ ПОЛУЧЕНИЯ И/ИЛИ СПОСОБЫ ЛЕЧЕНИЯ (TOPOTECAN MONOHYDROCHLORIDE PENTAHYDRATE IN CRYSTALLINE FORM, CORRESPONDING COMPOSITIONS BASED ON THEM, PREPARATION AND/OR TREATMENT METHODS)	⤷ Sign Up
Taiwan	200530250	Novel compound, corresponding compositions, preparation and/or treatment methods	⤷ Sign Up
Brazil	PI0416366	composto, composições correspondentes, métodos de preparação e/ou de tratamento	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for topotecan hydrochloride

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

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