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Generated: May 27, 2017

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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 patent protection?

Topotecan hydrochloride
is the generic ingredient in three branded drugs marketed by Sun Pharm Inds Ltd, Actavis Totowa, Mylan Labs Ltd, Accord Hlthcare, Teva Pharms Usa, Ingenus Pharms Llc, Chem Werth Inc, Novartis Pharms Corp, Fresenius Kabi Oncol, Hospira Inc, Sagent Pharms, Fresenius Kabi Usa, Dr Reddys Labs Ltd, Cipla Ltd, and Sandoz Inc, and is included in sixteen NDAs. There are two patents 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. Fourteen suppliers are listed for this compound.

Summary for Generic Name: topotecan hydrochloride

Drug Master File Entries: see list10
Suppliers / Packagers: see list14
Bulk Api Vendors: see list57
Clinical Trials: see list1,073
Patent Applications: see list6,394
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:topotecan hydrochloride at DailyMed

Pharmacology for Ingredient: topotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Ltd
topotecan hydrochloride
INJECTABLE;INJECTION091199-001Dec 1, 2010APRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
topotecan hydrochloride
INJECTABLE;INJECTION091542-001Aug 28, 2012APRXNoNo► Subscribe► Subscribe
Fresenius Kabi Oncol
topotecan hydrochloride
INJECTABLE;INJECTION091376-001Nov 29, 2010DISCNNoNo► Subscribe► Subscribe
Sandoz Inc
topotecan hydrochloride
SOLUTION;INTRAVENOUS200199-003Feb 25, 2011DISCNYesNo► Subscribe► Subscribe
Chem Werth Inc
topotecan hydrochloride
INJECTABLE;INJECTION201166-001Aug 8, 2012APRXNoNo► Subscribe► Subscribe
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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 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.

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