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Topotecan hydrochloride - Generic Drug Details

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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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient 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

Tradenames:3
Patents:1
Applicants:15
NDAs:16
Drug Master File Entries: see list10
Suppliers / Packagers: see list14
Bulk Api Vendors: see list57
Clinical Trials: see list1,071
Patent Applications: see list3,870
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 Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
INJECTABLE;INJECTION020671-001May 28, 1996RXYes► subscribe► subscribe
Sandoz Inc
TOPOTECAN
topotecan hydrochloride
SOLUTION;INTRAVENOUS200199-003Feb 25, 2011DISCNNo► subscribe► subscribe
Fresenius Kabi Oncol
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
INJECTABLE;INJECTION091376-001Nov 29, 2010DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: topotecan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
INJECTABLE;INJECTION020671-001May 28, 19965,674,872*PED► subscribe
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL020981-001Oct 11, 20075,004,758*PED► subscribe
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL020981-002Oct 11, 20075,004,758*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,754,733Crystalline topotecan hydrochloride product and process for making the same► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: topotecan hydrochloride

Country Document Number Estimated Expiration
European Patent Office1689400► subscribe
Taiwan200530250► subscribe
World Intellectual Property Organization (WIPO)2005046608► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TOPOTECAN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
70017Netherlands► subscribePRODUCT 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
C/GB96/057United Kingdom► subscribePRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
1997Austria► subscribePRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
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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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