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 — 40 recruiting, 59 active, 401 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines NCT04535401	Phase 1	Active	National Cancer Institute (NCI)	10	2021-08-13 → 2027-07-01
Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB NCT04776655	Phase 3	Active	Azienda USL Reggio Emilia - IRCCS	280	2021-04-30 → 2026-12
EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer NCT06011772	Early Phase 1	Active	Roswell Park Cancer Institute	2	2023-12-18 → 2029-02-05
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma NCT04743661	Phase 2	Active	Pediatric Brain Tumor Consortium	62	2022-04-04 → 2027-09-30
Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases NCT01792934	N/A	Active	Radboud University Medical Center	478	2013-05 → 2028-05
Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer NCT03764553	Phase 2	Active	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	320	2019-05-01 → 2026-12-01
Rapid Administration Pilot for Infusing Dinutuximab NCT05421897	Phase 2	Active	Children's Hospital Los Angeles	30	2022-11-29 → 2029-11
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)NCT04008030	Phase 3	Active	Bristol-Myers Squibb	839	2019-08-05 → 2027-03-23
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab NCT04211675	Phase 1/2	Active	Nationwide Children's Hospital	31	2022-09-01 → 2027-12
9-ING-41 in Patients With Advanced Cancers NCT03678883	Phase 2	Active	Actuate Therapeutics Inc.	350	2019-01-04 → 2026-06

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