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Last Updated: February 22, 2024

HYCAMTIN Drug Patent Profile


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

Hycamtin is a drug marketed by Sandoz 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. Six 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.

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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
G1 Therapeutics, Inc.Phase 4
Bristol-Myers SquibbPhase 2
Novartis PharmaceuticalsPhase 1/Phase 2

See all HYCAMTIN clinical trials

Pharmacology for HYCAMTIN
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase Inhibitors

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-001 Oct 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride CAPSULE;ORAL 020981-002 Oct 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz HYCAMTIN topotecan hydrochloride INJECTABLE;INJECTION 020671-001 May 28, 1996 ⤷  Try a Trial ⤷  Try a Trial
>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
Japan H01186893 WATER-SOLUBLE CAMPTOTHESINE ANALOGUE ⤷  Try a Trial
Norway 172391 ⤷  Try a Trial
Canada 1308102 ANALOGUES HYDROSOLUBLES DE LA CAMPTOTHECINE (WATER SOLUBLE CAMPTOTHECIN ANALOGS) ⤷  Try a Trial
European Patent Office 1689400 NOUVEAU COMPOSE, COMPOSITIONS CORRESPONDANTES, METHODES DE FABRICATION ET/OU DE TRAITEMENT (NOVEL COMPOUND, CORRESPONDING COMPOSITIONS, PREPARATION AND/OR TREATMENT METHODS) ⤷  Try a Trial
>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 ⤷  Try a Trial 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 SPC/GB96/057 United Kingdom ⤷  Try a Trial PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
0321122 97C0009 Belgium ⤷  Try a Trial PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
0321122 C970017 Netherlands ⤷  Try a Trial 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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Boehringer Ingelheim
McKinsey
Dow
Mallinckrodt

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