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:	75
Clinical Trials:	221
Patent Applications:	1,598
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	020571-001	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	020571-002	Jun 14, 1996

International Patents for CAMPTOSAR

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

Country	Patent Number	Title	Estimated Expiration
Canada	1235415	DERIVES DE LA CAMPTOTHECINE ET METHODE DE PREPARATION (CAMPTOTHECIN DERIVATIVES AND PROCESS FOR PREPARING SAME)
Luxembourg	90074
Germany	137145
World Intellectual Property Organization (WIPO)	0066125

Supplementary Protection Certificates for CAMPTOSAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	1790033-3	Sweden		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976	300885	Netherlands		PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
1746976	CA 2017 00030	Denmark		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)...; REG. NO/DATE: EU/1 /16/1130 20161018

Market Dynamics and Financial Trajectory for CAMPTOSAR (Irinotecan)

Last updated: July 27, 2025

Introduction

CAMPTOSAR (irinotecan) is a chemotherapy drug developed and marketed by Pfizer, primarily used to treat colorectal and other cancers. As a top-tier chemotherapeutic agent, it has carved a significant niche within oncology, driven by advances in personalized medicine and cancer treatment protocols. This comprehensive analysis elucidates the key market dynamics influencing CAMPTOSAR's trajectory, its positioning within the pharmaceutical landscape, and projected financial trends fueled by clinical, regulatory, and commercialization forces.

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Product Overview and Therapeutic Context

Irinotecan, branded as CAMPTOSAR, operates as a topoisomerase I inhibitor, impeding DNA replication in malignant cells. It has established itself in first-line and subsequent colorectal cancer (CRC) therapy (notably in FOLFIRI regimens), with expanded indications for gastric, lung, and pancreatic cancers. Its efficacy, combined with its inclusion in combination regimens, sustains steady demand, although competition and emerging therapies influence market share.

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Market Dynamics

1. Epidemiological Drivers

Cancer incidence, particularly CRC, remains a dominant driver. The Global Cancer Observatory estimates CRC cases exceeding 1.8 million annually globally, with rising prevalence in Asia-Pacific and emerging markets. Aging populations further underpin demand, as older demographics exhibit higher cancer susceptibility. These epidemiological trends sustain a relatively stable demand core for irinotecan-based therapies, with projections indicating continuous use over the next decade.

2. Therapeutic Pipeline and Competition

While CAMPTOSAR maintains clinical utility, its market position faces competition from newer agents such as immune checkpoint inhibitors (e.g., pembrolizumab), targeted therapies (e.g., anti-VEGF agents), and novel irinotecan formulations (liposomal or targeted delivery systems). The advent of personalized oncology, including biomarker-guided therapies, influences treatment sequencing and may impact irinotecan's market share.

Additionally, combination regimens incorporating CAMPTOSAR, such as FOLFIRI, are favored but also create opportunities for alternative combinations, especially with biologics, which could substitute or supplement irinotecan use.

3. Regulatory Environment and Guidelines

Regulatory approvals, including those by the FDA, EMA, and other agencies, advance product accessibility but also introduce compliance nuances. Changes in clinical guidelines, such as the NCCN or ESMO updates, can sway prescribing behaviors—either bolstering or limiting irinotecan's role.

Notably, regulatory pathways addressing biosimilars or generics could influence pricing and market competition, with patent expirations potentially on the horizon.

4. Pricing Strategies and Reimbursement

Pricing pressures are mounting globally, especially in cost-sensitive markets. Reimbursement policies and health technology assessments (HTAs) critically impact market penetration. Pfizer's negotiated pricing strategies and engagement with payers are essential to sustain revenue streams.

Cost-effectiveness analyses favoring combination therapies are also shaping market dynamics, often positioning CAMPTOSAR as part of lucrative regimens rather than a standalone in certain regions.

5. Manufacturing and Supply Chain Factors

Supply chain resilience, especially amid disruptions like global pandemics, influences availability and pricing. Pfizer's manufacturing capacity for irinotecan is robust, but capacity expansion or supply constraints could impact sales.

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Financial Trajectory Analysis

1. Revenue Trends

Historically, CAMPTOSAR's revenue has exhibited stability due to consistent demand in CRC treatment. Pfizer's fiscal reports indicate yearly revenues in the range of several hundred million USD, with modest growth or plateauing trends influenced by market saturation and competition.

Forecasts suggest a compound annual growth rate (CAGR) in the 2-4% range over the next five years, driven by:

• Increasing cancer prevalence globally.
• Expansion into new geographic markets.
• Adoption of combination therapy protocols.

2. Pricing and Market Penetration

While direct drug pricing faces downward pressures, volume-driven revenues may compensate, especially if Pfizer manages to expand indications or integrate irinotecan into emerging treatment algorithms.

Moreover, the potential launch of biosimilar or generic formulations in emerging markets could further influence revenue trajectories, either by introducing price competition or expanding access.

3. R&D and Pipeline Influence

Interest in next-generation formulations or combination strategies involving CAMPTOSAR could generate new revenue streams. Clinical trials exploring dose optimization, new indications, or adjunctive therapies may extend its market lifespan.

However, the inevitable patent expirations scheduled over the next decade threaten to compress margins unless Pfizer leverages its brand and pipeline assets or develops next-generation derivatives.

4. Strategic Collaborations and Licensing

Partnerships with regional distributors, cooperative clinical trials, and licensing agreements with biotech firms may influence overall financial performance. Such collaborations can facilitate market expansion, especially in untapped regions like Latin America and Africa.

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Market Outlook and Future Trends

Growth Models:

• Steady-State Demand: Driven by stable CRC incidence and established treatment practices.
• Innovation-Driven Growth: Dependent on formulation improvements (e.g., liposomal irinotecan) and personalized medicine breakthroughs.
• Competition Impact: Emergence of immunotherapies and targeted agents may gradually diminish irinotecan's relative market share in some indications, prompting a need for strategic repositioning.

Potential Challenges:

• Patent expiry risk.
• Pricing pressures driven by healthcare systems and payers.
• Rapid evolution of personalized and targeted therapies overshadowing traditional chemotherapeutics.

Opportunities:

• Expanding indications in other cancers, such as gastric or pancreatic.
• Developing combination regimens aligned with emerging biomarker profiles.
• Capitalizing on global cancer epidemiology trends, especially in low- and middle-income countries.

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Key Takeaways

• Market stability: CAMPTOSAR benefits from established clinical use, generating consistent revenue, with moderate growth prospects.
• Competitive landscape: New therapies and biosimilars could pressure pricing and market share, especially post-patent expiry.
• Pipeline importance: Development of next-generation formulations and expanded indications can prolong product lifecycle and revenue streams.
• Geographic expansion: Opportunities exist in emerging markets, contingent on pricing strategies and healthcare infrastructure.
• Strategic positioning: Emphasizing personalized medicine and combination therapies will be paramount to maintaining competitiveness.

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FAQs

1. How does CAMPTOSAR compare to newer chemotherapeutic agents?
While CAMPTOSAR remains effective for CRC, newer therapies, including targeted agents and immunotherapies, offer improved efficacy and fewer side effects. Nonetheless, irinotecan remains foundational in combination regimens due to its established efficacy and broad approval.

2. What is the impact of patent expiration on CAMPTOSAR’s financial performance?
Patent expiration can lead to generic versions entering the market, exerting pricing and market share pressures. Pfizer’s response involves maximizing existing indications, developing formulations, and expanding into new indications to sustain revenue.

3. Are there ongoing innovations in irinotecan formulations?
Yes, liposomal irinotecan (e.g., Nal-irinotecan) receives regulatory attention, offering potential for improved efficacy and reduced toxicity. Such innovations can provide competitive advantages and new revenue streams.

4. What role do regulatory agencies play in CAMPTOSAR's market trajectory?
Regulatory approvals facilitate market access, while guideline endorsements influence prescribing behaviors. Simultaneously, reforms in reimbursement policies can either hinder or promote sales.

5. How significant is the global burden of CRC for CAMPTOSAR’s future?
The rising incidence of CRC worldwide, especially in Asia and Latin America, suggests sustained demand. The aging population further amplifies this trend, underpinning the product's long-term market outlook.

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Conclusion

CAMPTOSAR’s market dynamics hinge on a confluence of epidemiological trends, therapeutic innovation, regulatory environments, and strategic commercialization. While facing challenges from emerging therapies and patent expiries, its entrenched role in CRC treatment and potential expansion into new indications afford it a resilient, albeit competitive, financial trajectory. Continuous innovation, geographic expansion, and adaptation to evolving clinical guidelines remain vital to sustaining Pfizer’s position and maximizing long-term value from this established chemotherapeutic agent.

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Sources:

[1] Global Cancer Observatory (GLOBOCAN). Cancer Statistics. 2022.
[2] Pfizer Annual Reports. 2020-2022.
[3] National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. 2023.
[4] Market Research Future. "Global Chemotherapy Market Analysis." 2022.
[5] FDA Drug Approval Records. 2021-2023.