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CAMPTOSAR Drug Profile

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Camptosar is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. 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 drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for Tradename: CAMPTOSAR

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: CAMPTOSAR

Clinical Trials for: CAMPTOSAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996RXYes6,794,370*PED<disabled>Y<disabled>
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-002Jun 14, 1996RXYes6,403,569*PED<disabled>Y<disabled>
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996RXYes6,403,569*PED<disabled>Y<disabled>
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Expired Patents for Tradename: CAMPTOSAR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 19964,604,463*PED<disabled>
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-002Jun 14, 19964,604,463*PED<disabled>
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Paragraph IV activity for: CAMPTOSAR

Drugname Dosage Strength RLD Submissiondate
irinotecan hydrochlorideInjection20 mg/mL, 2 mL and 5 mL vialsCamptosar7/26/2004

International Patent Family for Tradename: CAMPTOSAR

Country Document Number Estimated Expiration
Australia4564200<disabled in preview>
World Intellectual Property Organization (WIPO)0066125<disabled in preview>
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Supplementary Protection Certificates for Tradename: CAMPTOSAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB97/010United Kingdom<disabled>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
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