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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Cantor Fitzgerald
Merck
Baxter
Farmers Insurance
US Army
Healthtrust
Cerilliant
Fuji

Generated: January 17, 2018

DrugPatentWatch Database Preview

HYCAMTIN Drug Profile

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When do Hycamtin patents expire, and what generic alternatives are available?

Hycamtin is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There is one patent protecting this drug.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in HYCAMTIN is topotecan hydrochloride. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Drug patent expirations by year for HYCAMTIN
Pharmacology for HYCAMTIN
Medical Subject Heading (MeSH) Categories for HYCAMTIN

US Patents and Regulatory Information for HYCAMTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis Pharms Corp HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 HYCAMTIN

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

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Non-Orange Book US Patents for HYCAMTIN

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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for HYCAMTIN

Supplementary Protection Certificates for HYCAMTIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/057 United Kingdom ➤ Subscribe 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 ➤ Subscribe PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
C0009 Belgium ➤ Subscribe PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
70017 Netherlands ➤ Subscribe 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 leading biopharmaceutical companies globally:

Cipla
UBS
Boehringer Ingelheim
Healthtrust
Dow
Mallinckrodt
Federal Trade Commission
Cerilliant
Daiichi Sankyo

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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