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Last Updated: June 23, 2024

CAMPTOSAR Drug Patent Profile


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When do Camptosar patents expire, and when can generic versions of Camptosar launch?

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

The generic ingredient in CAMPTOSAR is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen 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 27th, 2008.

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Drug patent expirations by year for CAMPTOSAR
Drug Prices for CAMPTOSAR

See drug prices for CAMPTOSAR

Recent Clinical Trials for CAMPTOSAR

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

SponsorPhase
University of California, San FranciscoPhase 1
GlaxoSmithKlinePhase 1
Kimberly PerezPhase 2

See all CAMPTOSAR clinical trials

Pharmacology for CAMPTOSAR
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase Inhibitors
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-003 Aug 5, 2010 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 CAMPTOSAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CAMPTOSAR

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

Country Patent Number Title Estimated Expiration
Japan H034077 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 0066125 ⤷  Sign Up
Netherlands 980026 ⤷  Sign Up
Germany 3470744 ⤷  Sign Up
Germany 137145 ⤷  Sign Up
European Patent Office 0137145 NEW CAMPTOTHECIN DERIVATIVES AND PROCESS FOR PREPARING SAME ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CAMPTOSAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 132017000076571 Italy ⤷  Sign Up PRODUCT NAME: SALE SUCROSOFATO DI IRINOTECAN, COME IL SALE SUCROSOFATO DI IRINOTECAN IN UN LIPOSOMA PEGILATO(ONIVYDE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1130, 20161018
1746976 CR 2017 00030 Denmark ⤷  Sign Up PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
1746976 C01746976/01 Switzerland ⤷  Sign Up PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976 LUC00026 Luxembourg ⤷  Sign Up 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 ⤷  Sign Up 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
1746976 2017C/027 Belgium ⤷  Sign Up PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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