Viewing data from:

CAMPTOSAR

NDA

IRINOTECAN HYDROCHLORIDE | N020571 | PFIZER INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer NCT07662031	Phase 2	Not Yet Recruiting	Washington University School of Medicine	25	2026-08-31 → 2032-08-31
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC NCT06478043	Phase 2	Completed	Zhejiang Cancer Hospital	60	2024-10-16 → 2025-08-27
Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors: A Prospective Pilot Study NCT05507736	N/A	Completed	Fundació Sant Joan de Déu	22	2022-10-01 → 2024-08-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Camptosar (2023)

Total Spending

$1.5M

Total Claims

47,158

Beneficiaries

7,056

ASP Price

—

HCPCS: J9206 — Injection, irinotecan, 20 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain14 active DMFs15 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

SCINOPHARM TAIWAN LTDIRINOTECAN HYDROCHLORIDE

DMF 173122004

PLIVA-LACHEMA ASIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 190502005

FERMION OYIRINOTECAN HYDROCHLORIDE

DMF 206492007

JIANGSU HENGRUI PHARMACEUTICALS CO LTDIRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE

DMF 207392007

OLON SPAIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 215002008

LAURUS LABS LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 222962008

EMCURE PHARMACEUTICALS LTDIRINOTECAN HYDROCHLORIDE USP

DMF 232202009

HUBEI HAOSUN PHARMACEUTICAL CO LTDIRINOTECAN HYDROCHLORIDE

DMF 235222010

SHILPA PHARMA LIFESCIENCES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 235622010

QILU PHARMACEUTICAL CO LTDIRINOTECAN HYDROCHLORIDE (NON STERILE, API)

DMF 241332010

ARCH PHARMALABS LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 246432011

HETERO LABS LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B)

DMF 256862012

SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 302612016

SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE USP

DMF 326752018

CIPLA LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 174562004

FRESENIUS KABI ONCOLOGY LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 188182005

POLYMED THERAPEUTICS INCInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE

DMF 189692005

SAI PHYTOCEUTICALS PVT LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 196612006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 201952007

POLYMED THERAPEUTICS INCInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 202232007

DR REDDYS LABORATORIES LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 203252007

LIANYUNGANG JARI PHARMACEUTICAL CO LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 217462008

ALP PHARM BEIJING CO LTDInactiveIRINOTECAN HYDROCHLORIDE

DMF 239492010

CADILA HEALTHCARE LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 239822010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveIRINOTECAN HYDROCHLORIDE

DMF 246532011

AVRA LABORATORIES PRIVATE LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 256932012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

DMF 265542012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 277242013

AVRA LABORATORIES PRIVATE LTDInactiveIRINOTECAN HYDROCHLORIDE USP

DMF 305162016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
May 20, 2024	SUPPL -56	View Letter (PDF)
Jan 31, 2022	SUPPL -53	View Letter (PDF)
Jan 31, 2020	SUPPL -51	View Letter (PDF)
Dec 23, 2014	SUPPL -48	View Letter (PDF)
Jul 17, 2012	SUPPL -42	View Letter (PDF)
May 21, 2010	SUPPL -33	View Letter (PDF)
May 21, 2010	SUPPL -32	View Letter (PDF)
May 21, 2010	SUPPL -31	View Letter (PDF)
May 21, 2010	SUPPL -37	View Letter (PDF)
May 21, 2010	SUPPL -36	View Letter (PDF)
Aug 4, 2006	SUPPL -30	View Letter (PDF)
Jul 26, 2005	SUPPL -24	View Letter (PDF)
Jul 26, 2005	SUPPL -27	View Letter (PDF)
Jul 26, 2005	SUPPL -28	View Letter (PDF)
Jun 8, 2005	SUPPL -26	View Letter (PDF)
Dec 8, 2004	SUPPL -23	View Letter (PDF)
Jun 25, 2004	SUPPL -21	View Letter (PDF)
May 16, 2002	SUPPL -16	View Letter (PDF)
Apr 20, 2000	SUPPL -9	View Letter (PDF)
Oct 22, 1998	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG/2ML (20MG/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 14, 1996

No patent or exclusivity listings for this strength.

#002 — 100MG/5ML (20MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 14, 1996

#003 — 300MG/15ML (20MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 5, 2010