CAMPTOSAR Drug Patent Profile

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

Camptosar is a drug marketed by Pfizer Inc and is included in one NDA.

The generic ingredient in CAMPTOSAR is irinotecan hydrochloride. Thirteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Camptosar

A generic version of CAMPTOSAR was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27^th, 2008.

Summary for CAMPTOSAR

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for CAMPTOSAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAMPTOSAR	Injection	irinotecan hydrochloride	20 mg/mL, 2 mL and 5 mL vials	020571	1	2004-07-26

US Patents and Regulatory Information for CAMPTOSAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-001	Jun 14, 1996	AP	RX	Yes	Yes
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-002	Jun 14, 1996	AP	RX	Yes	Yes
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-003	Aug 5, 2010	AP	RX	Yes	Yes

International Patents for CAMPTOSAR

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

Country	Patent Number	Title	Estimated Expiration
Austria	33839
Canada	1235415	DERIVES DE LA CAMPTOTHECINE ET METHODE DE PREPARATION (CAMPTOTHECIN DERIVATIVES AND PROCESS FOR PREPARING SAME)
Germany	137145
Germany	3470744
European Patent Office	0137145	NEW CAMPTOTHECIN DERIVATIVES AND PROCESS FOR PREPARING SAME
Japan	H034077
Japan	S6019790	NOVEL CAMPTOTHECIN DERIVATIVE

Supplementary Protection Certificates for CAMPTOSAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	CR 2017 00030	Denmark		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
1746976	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1746976	C01746976/01	Switzerland		PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
0137145	SPC/GB97/010	United Kingdom		PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
1746976	LUC00026	Luxembourg		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1746976	CA 2017 00030	Denmark		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018