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
GlaxoSmithKline	Phase 1
University of California, San Francisco	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

International Patents for CAMPTOSAR

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

Country	Patent Number	Title	Estimated Expiration
Australia	4564200
European Patent Office	0137145	NEW CAMPTOTHECIN DERIVATIVES AND PROCESS FOR PREPARING SAME
Austria	33839
Japan	S6019790	NOVEL CAMPTOTHECIN DERIVATIVE
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	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
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	17C1027	France		PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: 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
1746976	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018

CAMPTOSAR (irinotecan): Market dynamics and financial trajectory

Last updated: April 23, 2026

CAMPTOSAR (irinotecan) is a chemotherapy backbone in metastatic colorectal cancer and other irinotecan-used oncology settings. The market is shaped by patent and exclusivity timelines, reliance on hospital dispensing and oncology protocols, and steady cannibalization of any legacy brand premium by branded generics and authorized generics in major geographies.

What is CAMPTOSAR’s market positioning by use and uptake dynamics?

Core molecule and role

• Drug: irinotecan (CPT-11), topoisomerase I inhibitor
• Product: CAMPTOSAR (brand)
• Primary clinical use mix (protocol-driven):
  • Metastatic colorectal cancer
  • Used in multi-agent regimens that drive repeat prescribing and inventory planning in hospital oncology systems

Demand mechanics

1. Protocol-based prescribing
   • Irinotecan use is driven by regimen guidelines and lines of therapy rather than patient-by-patient customization.
2. Hospital-centric procurement
   • Uptake is influenced by tender cycles, formulary inclusion, and negotiated pricing rather than retail market dynamics.
3. Substitution pressure
   • Once priced materially below the brand, generics and authorized generics typically capture most market volume in mature markets.

Competitive landscape

• Brand-to-generic transition risk: CAMPTOSAR faces structural pricing compression once multiple market entrants are in place.
• Class competition: While CAMPTOSAR is specific to irinotecan, hospital oncology formularies can reweight across alternative regimens when payer and guideline preferences shift, affecting total irinotecan throughput.

How have patent and exclusivity forces affected the commercial path?

Therapeutic area and molecule maturity

• Irinotecan is a mature oncology cytotoxic with long-standing global availability, which generally implies:
  • Limited brand premium durability
  • Faster uptake of authorized generics
  • Contracted pricing pressure

Impact on CAMPTOSAR revenue trajectory

• Early-stage brand value: highest when market exclusivity blocks competition or when competing presentations are limited.
• Post-exclusivity compression: revenue typically declines as:
  • Generic entrants expand
  • Authorized generics cap pricing upside
  • Formularies standardize to lower-cost supply

What do market dynamics imply for pricing and volume?

Price dynamics

• Expect a downward price trajectory over time due to:
  • Generic substitution
  • Tender-based contracting
  • Limited differentiation of the API in routine use

Volume dynamics

• In mature oncology cytotoxic markets, volume can remain relatively stable in absolute terms while revenue declines due to price erosion.
• Net revenue performance usually depends on:
  • Whether CAMPTOSAR retains any premium in certain sub-markets (supply assurance, legacy contracting, limited tender overrides)
  • Whether the company maintains distribution reach and avoids share loss to lower-cost alternatives

Portfolio mechanics

• Revenue is also sensitive to:
  • Regimen mix shifts within metastatic colorectal cancer (for example, use patterns within first vs later lines)
  • Combination therapy utilization rates across systems

What is the expected financial trajectory across a typical branded cytotoxic cycle?

A branded oncology cytotoxic like CAMPTOSAR typically experiences a revenue pattern consistent with exclusivity expiry and generic penetration:

Trajectory model for CAMPTOSAR

Phase	Market condition	Revenue direction	Typical driver
Pre-expiry	Limited competition; brand premium	Growth or stability	Exclusivity and protocol fit
Transition	First competitive entries; tenders begin switching	Flat to declining	Price pressure and share erosion
Mature generic era	Multiple suppliers; procurement standardization	Decline with volatility	Pricing levels, supply contracts, and tender outcomes

Key business outcomes that usually follow

• Gross margin compression as pricing converges toward generic benchmarks.
• Market share dilution if brand is not contractually favored.
• Reduced marketing leverage as clinicians and pharmacists shift to lowest-cost options within formularies.

What are the commercialization levers that influence CAMPTOSAR’s revenue path?

1. Formulary inclusion and tender strategy
   • Where the brand is locked in through contracts, revenue tends to decline slower.
2. Supply assurance and distribution reliability
   • In hospital procurement, consistent supply can protect a portion of share even against lower-priced competitors.
3. Regimen utilization and line-of-therapy mix
   • Irinotecan demand can shift with chemotherapy standards and comparative regimen choices, impacting total addressable volume.

Where are the major inflection points likely to occur?

For a mature cytotoxic brand, inflection points typically align with:

• Patent or data exclusivity expiries
• Launch timing of competitors
• Authorized generic introductions
• Formulary refresh cycles in large hospital systems

Because CAMPTOSAR is in a mature class, the largest inflection points occur at entry milestones rather than clinical events.

Financial trajectory: what investors should watch for (without generic theory)?

A credible earnings and cashflow lens for CAMPTOSAR follows procurement economics:

Metrics tied to revenue performance

• ASP trend vs generic benchmark (price compression pace)
• Volume share in hospital tenders (where brand persists)
• Distribution and rebate structure impacts (net vs gross)
• Service and supply costs (cytotoxic handling logistics can affect net margin)

Where CAMPTOSAR performance diverges most from generic-only expectations

• Contract retention in certain regions
• Narrow tender windows that allow partial continuity even after new entrants
• Regional supply constraints that briefly protect revenue

Key Takeaways

• CAMPTOSAR’s market is protocol-driven and hospital procurement led, which makes volume steadier than price.
• Patent and exclusivity timelines typically drive the major shifts: early brand premium transitions into sustained pricing compression as generics and authorized generics expand.
• Revenue tends to decline over time as price converges to generic benchmarks, with the brand’s persistence depending on contract coverage, supply reliability, and tender dynamics.
• The highest business relevance for CAMPTOSAR’s financial trajectory comes from pricing vs generic parity and the durability of formulary access, not from incremental clinical differentiation.

FAQs

1) Is CAMPTOSAR’s demand more volume-led or price-led today?

In mature markets, revenue is usually price-led, with volume stability constrained by substitution once formularies and tenders switch to lower-cost alternatives.

2) What drives CAMPTOSAR sales most directly in hospitals?

Formulary inclusion, tender award timing, and contract pricing for chemotherapy procurement, since irinotecan is used through standardized oncology regimens.

3) How do generic entrants typically affect CAMPTOSAR revenue?

They usually trigger rapid ASP compression and share dilution, causing revenue decline even if underlying irinotecan protocol demand remains steady.

4) Do clinical outcomes change CAMPTOSAR’s financial trajectory?

Clinical effectiveness affects long-term protocol placement, but for a mature cytotoxic, financial trajectory is more tightly linked to exclusivity and procurement economics.

5) What are the most common inflection triggers for a branded cytotoxic?

Exclusivity expiration, competitor launch timing, and formulary/tender refresh cycles.

References

[1] FDA. Drug Approval Package: CAMPTOSAR (irinotecan hydrochloride). U.S. Food and Drug Administration.
[2] EMA. Public assessment reports and EPAR information for irinotecan products. European Medicines Agency.
[3] DailyMed. CAMPTOSAR prescribing information (irinotecan hydrochloride). U.S. National Library of Medicine.
[4] WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD and drug utilization datasets (irinotecan). World Health Organization.