Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Harvard Business School
McKinsey
Dow
Mallinckrodt

Last Updated: September 25, 2022

HYCAMTIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


Which patents cover Hycamtin, and when can generic versions of Hycamtin launch?

Hycamtin is a drug marketed by Novartis 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. Nine suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hycamtin

A generic version of HYCAMTIN was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29th, 2010.

  Try it Free

Summary for HYCAMTIN
Drug patent expirations by year for HYCAMTIN
Drug Prices for HYCAMTIN

See drug prices for HYCAMTIN

Recent Clinical Trials for HYCAMTIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novartis PharmaceuticalsPhase 1/Phase 2
Innovative Therapies For Children with Cancer ConsortiumPhase 1/Phase 2
Merck Sharp & Dohme Corp.Phase 3

See all HYCAMTIN clinical trials

Pharmacology for HYCAMTIN

US Patents and Regulatory Information for HYCAMTIN

HYCAMTIN is protected by one US patents.

Patents protecting HYCAMTIN

Compound, corresponding compositions, preparation and/or treatment methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 See Plans and Pricing See Plans and Pricing
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 See Plans and Pricing See Plans and Pricing
Novartis HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 See Plans and Pricing See Plans and Pricing
Novartis HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HYCAMTIN

See the table below for patents covering HYCAMTIN around the world.

Country Patent Number Title Estimated Expiration
Taiwan 200530250 Novel compound, corresponding compositions, preparation and/or treatment methods See Plans and Pricing
Finland 89923 See Plans and Pricing
Brazil PI0416366 composto, composições correspondentes, métodos de preparação e/ou de tratamento See Plans and Pricing
Australia 2004289318 Novel compound, corresponding compositions, preparation and/or treatment methods See Plans and Pricing
China 1083817 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HYCAMTIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0321122 2/1997 Austria See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
0321122 SPC/GB96/057 United Kingdom See Plans and Pricing PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
0321122 C970017 Netherlands See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Boehringer Ingelheim
McKinsey
Dow
Mallinckrodt

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 verification 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.