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. Seven 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 29^th, 2010.

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Summary for HYCAMTIN

International Patents:	18
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	118
Patent Applications:	7,136
Drug Prices:	Drug price information for HYCAMTIN
What excipients (inactive ingredients) are in HYCAMTIN?	HYCAMTIN excipients list
DailyMed Link:	HYCAMTIN at DailyMed

Drug patent expirations by year for HYCAMTIN

Recent Clinical Trials for HYCAMTIN

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

Sponsor	Phase
European Network of Gynaecological Oncological Trial Groups (ENGOT)	Phase 3
Verastem, Inc.	Phase 3
GOG Foundation	Phase 3

See all HYCAMTIN clinical trials

Pharmacology for HYCAMTIN

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase 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: ⤷ Sign Up
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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-001	Oct 11, 2007	⤷ Sign Up	⤷ Sign Up
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996	⤷ Sign Up	⤷ Sign Up
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Cyprus	2017	Water soluble camptothecin analogs	⤷ Sign Up
Norway	912386		⤷ Sign Up
Netherlands	970017		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for HYCAMTIN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0321122	2/1997	Austria	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
0321122	C970017	Netherlands	⤷ Sign Up	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