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Last Updated: November 29, 2020

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CAMPTOSAR Drug 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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

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.

Drug patent expirations by year for CAMPTOSAR
Drug Prices for CAMPTOSAR

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Recent Clinical Trials for CAMPTOSAR

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

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2
Nationwide Children's HospitalPhase 1/Phase 2

See all CAMPTOSAR clinical trials

Pharmacology for CAMPTOSAR
Paragraph IV (Patent) Challenges for CAMPTOSAR
Tradename Dosage Ingredient NDA Submissiondate
CAMPTOSAR INJECTABLE;INJECTION irinotecan hydrochloride 020571 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   Start Trial   Start Trial Y   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-003 Aug 5, 2010 AP RX Yes Yes   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CAMPTOSAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 1790033-3 Sweden   Start Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976 300885 Netherlands   Start Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 2017C/027 Belgium   Start Trial 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
1746976 CA 2017 00030 Denmark   Start Trial 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
0137145 SPC/GB97/010 United Kingdom   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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