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

500 trials from ClinicalTrials.gov — 20 recruiting, 35 active, 388 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Irinotecan, Temozolomide and Bevacizumab in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Newly Diagnosed Patients With Desmoplastic Small Round Cell Tumor NCT01189643	Early Phase 1	Active	Memorial Sloan Kettering Cancer Center	15	2010-08 → 2026-08
Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients NCT03829462	Phase 3	Active	Institut du Cancer de Montpellier - Val d'Aurelle	377	2019-03-28 → 2026-09
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy NCT01871766	Phase 2	Active	St. Jude Children's Research Hospital	115	2013-12-04 → 2030-06
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer NCT04005339	Phase 2	Active	Georgetown University	48	2019-07-29 → 2026-12-31
A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma NCT03483038	Phase 2	Active	University of Florida	45	2018-12-13 → 2026-12
M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery NCT02595931	Phase 1	Active	National Cancer Institute (NCI)	66	2016-07-22 → 2027-03-06
9-ING-41 in Patients With Advanced Cancers NCT03678883	Phase 2	Active	Actuate Therapeutics Inc.	350	2019-01-04 → 2026-06
Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors NCT00045201	Phase 1	Active	National Cancer Institute (NCI)	60	2002-06-13 → 2026-08-22
Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery NCT03533582	Phase 3	Active	Children's Oncology Group	537	2018-05-24 → 2026-12-31
Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status.NCT04348045	Phase 2	Active	GERCOR - Multidisciplinary Oncology Cooperative Group	307	2020-12-07 → 2025-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$9.91

Highest Price

$40.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-0082-02CAMPTOSAR 20MG/ML INJ	$40.74	FSS	Pfizer Inc.	06/30/2029
00009-0082-02CAMPTOSAR 20MG/ML INJ	$40.74	Big4	Pfizer Inc.	06/30/2029
00009-0112-05CAMPTOSAR	$13.07	FSS	Pfizer Inc.	06/30/2029
00009-0112-05CAMPTOSAR	$9.91	Big4	Pfizer Inc.	06/30/2029
00009-7529-03CAMPTOSAR	$13.07	FSS	Pfizer Inc.	06/30/2029
00009-7529-03CAMPTOSAR	$9.91	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part B Spending

CMS physician-administered drug spending for Camptosar (2024)

Total Spending

$1.6M

Total Claims

46,104

Beneficiaries

6,928

ASP Price

$2.67

Spending Trend

$2.1M(2019)→$2.0M(2020)→$1.7M(2021)→$1.6M(2022)→$1.5M(2023)→$1.6M(2024)

YoY Change:+10.5%

5yr CAGR:+0.8%

HCPCS: J9206 — Injection, irinotecan, 20 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain15 active DMFs15 inactive

14 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

COHANCE LIFESCIENCES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DMF 436772026

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