CAMPTOSAR Drug Patent Profile

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.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Camptosar

A generic version of CAMPTOSAR was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27^th, 2008.

Summary for CAMPTOSAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	204
Clinical Trials:	221
Patent Applications:	4,254
Drug Prices:	Drug price information for CAMPTOSAR
What excipients (inactive ingredients) are in CAMPTOSAR?	CAMPTOSAR excipients list
DailyMed Link:	CAMPTOSAR at DailyMed

See drug prices for CAMPTOSAR

Recent Clinical Trials for CAMPTOSAR

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

Sponsor	Phase
University of California, San Francisco	Phase 1
GlaxoSmithKline	Phase 1
Kimberly Perez	Phase 2

See all CAMPTOSAR clinical trials

Pharmacology for CAMPTOSAR

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Paragraph IV (Patent) Challenges for CAMPTOSAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAMPTOSAR	Injection	irinotecan hydrochloride	20 mg/mL, 2 mL and 5 mL vials	020571	1	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
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-002	Jun 14, 1996	AP	RX	Yes	Yes
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-003	Aug 5, 2010	AP	RX	Yes	Yes

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
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-001	Jun 14, 1996
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-002	Jun 14, 1996
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-002	Jun 14, 1996
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-001	Jun 14, 1996

International Patents for CAMPTOSAR

See the table below for patents covering CAMPTOSAR around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3470744
World Intellectual Property Organization (WIPO)	0066125
European Patent Office	0137145	NEW CAMPTOTHECIN DERIVATIVES AND PROCESS FOR PREPARING SAME
Austria	33839
Japan	H034077

Supplementary Protection Certificates for CAMPTOSAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	LUC00026	Luxembourg		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
1746976	2017C/027	Belgium		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
0137145	SPC/GB97/010	United Kingdom		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	132017000076571	Italy		PRODUCT NAME: SALE SUCROSOFATO DI IRINOTECAN, COME IL SALE SUCROSOFATO DI IRINOTECAN IN UN LIPOSOMA PEGILATO(ONIVYDE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1130, 20161018
1746976	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018

CAMPTOSAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Camptosar (Irinotecan)

Market Overview

Camptosar, also known as irinotecan, is a chemotherapy drug used primarily in the treatment of colorectal cancer. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Global Irinotecan Market Size and Growth

The global irinotecan market was valued at USD 9.2 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2023 to 2030[1].

Market Segmentation

Geographical Analysis

• North America: This region dominated the irinotecan market in 2023, accounting for more than 38% of the global revenue. The strong healthcare system, significant investments in pharmaceutical R&D, and a higher incidence of cancer, particularly colorectal cancer, contribute to this dominance. Regulatory approvals and a well-defined healthcare reimbursement system also play crucial roles[1].
• Europe: Europe holds a substantial share of the global irinotecan market, driven by advanced healthcare infrastructure and a high incidence of cancer cases.
• Asia Pacific: This region is growing rapidly due to its large and developing population, rising cancer cases, cost-effective manufacturing capabilities, and improved access to healthcare. Investments in pharmaceutical R&D, especially in cancer therapies, are also driving growth[1].
• South America and Middle East & Africa: These regions have smaller but growing markets, driven by increasing cancer incidence and population growth, along with developing pharmaceutical research and healthcare infrastructure[1].

Market Drivers

Increasing Incidence of Colorectal Cancer

The global colorectal cancer drugs market, which includes irinotecan, is driven by the increasing incidence of colorectal cancer. This market is estimated to grow from USD 10.23 billion in 2023 to USD 12.79 billion by 2028, with a CAGR of 4.57%[2][4].

Advanced Healthcare Infrastructure

Regions with well-established healthcare facilities and access to cutting-edge therapeutic options, such as North America, drive the demand for irinotecan. The presence of sophisticated healthcare infrastructure and clearly defined reimbursement mechanisms further fuels this demand[1].

Regulatory Approvals and Precision Medicine

Regulatory approvals for innovative treatments and the emphasis on precision medicine are significant drivers for the irinotecan market. These factors contribute to the market's growth by providing more effective and targeted cancer treatments[1].

Financial Performance

Revenue Projections

The global irinotecan market is expected to continue its growth trajectory, with a projected CAGR of 6.5% from 2023 to 2030. This growth is supported by the increasing demand for effective cancer treatments and the expanding reach of healthcare services globally[1].

Regional Revenue Breakdown

• North America: USD 3.496 billion in 2023
• Europe: USD 2.944 billion in 2023
• Asia Pacific: USD 2.116 billion in 2023
• South America: USD 0.46 billion in 2023
• Middle East and Africa: USD 0.184 billion in 2023[1].

Competitive Landscape

Key Players

The market for colorectal cancer drugs, including irinotecan, is competitive with several key players. Companies like Pfizer, which manufactures Camptosar, and other pharmaceutical giants are actively involved in R&D and commercialization of cancer therapies. Seagen Inc., for example, has a robust oncology pipeline and has reported significant revenue growth from its cancer treatment products[3].

Challenges and Opportunities

Side Effects and Management

Irinotecan is associated with significant side effects, such as late diarrhea, which can be life-threatening. Managing these side effects is crucial for patient care and can impact the drug's market performance. The availability of treatments like loperamide to manage late diarrhea is essential[5].

Economic and Regulatory Factors

Market dynamics are influenced by economic factors, including the impact of economic slowdowns and potential recessions. Regulatory approvals and changes in healthcare policies also play a critical role in shaping the market trajectory[2][4].

Strategic Insights

Market Development and Penetration

Companies are focusing on market development through the introduction of new treatments and expanding into new geographical regions. Market penetration strategies include enhancing existing product lines and improving distribution channels[2].

Product Development and Diversification

The emphasis on product development is high, with companies investing heavily in R&D to develop more effective and targeted cancer therapies. Diversification into other cancer treatment areas is also a strategic move to capture a broader market share[2].

Key Takeaways

• The global irinotecan market is valued at USD 9.2 billion in 2023 and is expected to grow at a CAGR of 6.5% until 2030.
• North America dominates the market due to its strong healthcare system and high incidence of cancer.
• The Asia Pacific region is growing rapidly due to its large population and improving healthcare infrastructure.
• Regulatory approvals and precision medicine are key drivers for the market.
• Managing side effects and navigating economic and regulatory challenges are critical for market success.

FAQs

What is the current market size of the global irinotecan market?

The global irinotecan market was valued at USD 9.2 billion in 2023[1].

What is the projected growth rate of the global irinotecan market?

The global irinotecan market is projected to grow at a CAGR of 6.5% from 2023 to 2030[1].

Which region dominates the irinotecan market?

North America dominates the irinotecan market, accounting for more than 38% of the global revenue in 2023[1].

What are the key drivers for the irinotecan market?

Key drivers include the increasing incidence of colorectal cancer, advanced healthcare infrastructure, regulatory approvals, and the emphasis on precision medicine[1][2].

What are the significant side effects associated with irinotecan?

Irinotecan is associated with late diarrhea, which can be life-threatening and may lead to dehydration, electrolyte imbalance, or sepsis[5].

How is the competitive landscape for irinotecan?

The market is competitive with key players like Pfizer and Seagen Inc., which are actively involved in R&D and commercialization of cancer therapies[1][3].