Irinotecan hydrochloride - Generic Drug Details

What are the generic sources for irinotecan hydrochloride and what is the scope of freedom to operate?

Irinotecan hydrochloride is the generic ingredient in three branded drugs marketed by Ipsen, Pfizer Inc, Accord Hlthcare, Actavis Totowa, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pharmobedient, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, and Teva Pharms Usa, and is included in twenty-eight NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has one hundred and sixty-two patent family members in twenty-nine countries.

There are thirty drug master file entries for irinotecan hydrochloride. Sixteen suppliers are listed for this compound.

Summary for irinotecan hydrochloride

International Patents:	162
US Patents:	20
Tradenames:	3
Applicants:	25
NDAs:	28
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,758
Patent Applications:	5,514
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for irinotecan hydrochloride
What excipients (inactive ingredients) are in irinotecan hydrochloride?	irinotecan hydrochloride excipients list
DailyMed Link:	irinotecan hydrochloride at DailyMed

Recent Clinical Trials for irinotecan hydrochloride

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE3
SWOG Cancer Research Network	PHASE3
Medical University of South Carolina	PHASE2

See all irinotecan hydrochloride clinical trials

Pharmacology for irinotecan hydrochloride

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for irinotecan hydrochloride

L01CE	Topoisomerase 1 (TOP1) inhibitors
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IRINOTECAN HYDROCHLORIDE

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 irinotecan hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	078796-001	Feb 27, 2008	AP	RX	No	Yes
Hisun Pharm Hangzhou	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	090016-002	Jan 28, 2009		DISCN	No	No
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	11,344,552
Hikma Farmaceutica	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	091032-001	Dec 20, 2010	AP	RX	No	No
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	9,782,349		Y	Y

Expired US Patents for irinotecan hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	9,730,891
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	10,722,508
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-001	Jun 14, 1996	6,403,569*PED
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-001	Jun 14, 1996	4,604,463*PED
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	9,782,349

International Patents for irinotecan hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	201831168	Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Taiwan	202400181
European Patent Office	3362049
China	107811971	用于药物输送的脂质体 (Liposomes useful for drug delivery)
Taiwan	201412345	Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan

Supplementary Protection Certificates for irinotecan hydrochloride

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	C01746976/01	Switzerland		PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
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
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	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018

Market Dynamics and Financial Trajectory for Irinotecan Hydrochloride

Last updated: July 27, 2025

Introduction

Irinotecan hydrochloride, a semi-synthetic derivative of camptothecin, is a pivotal chemotherapeutic agent primarily utilized in the treatment of colorectal and other gastrointestinal cancers. Approved by the U.S. FDA in 1994, it functions as a topoisomerase I inhibitor, disrupting DNA replication in malignant cells. Over the past decades, its market profile has been shaped by evolving cancer treatment paradigms, patent landscapes, and competitive dynamics. This analysis explores the current market forces and financial trajectory likely to influence irinotecan hydrochloride's commercial landscape in the near and medium terms.

Market Overview

The global cancer therapeutics market, projected to reach USD 250 billion by 2028, underpins the demand for agents like irinotecan hydrochloride. Its core applications lie in colorectal, lung, pancreatic, and gastric cancers, aligning with increasing cancer incidence rates worldwide. According to global cancer statistics, colorectal cancer ranks as the third most prevalent malignancy, underscoring a sustained need for effective chemotherapies, including irinotecan [1].

Irinotecan's revenues derive from both branded formulations, such as Camptosar (manufactured by Pfizer), and generic versions. The drug's spending is influenced by factors like patent expiration, emergence of biosimilars or generics, and shifts towards combination therapies.

Market Drivers

1. Growing Incidence of Target Cancers
   The rising prevalence of colorectal and gastrointestinal cancers, especially in aging populations, fuels incremental demand. In developed nations, screening programs have increased early diagnosis, often leading to combination chemotherapies where irinotecan features prominently [2].

2. Advancements in Combination Therapy Regimens
   Clinical trials increasingly validate irinotecan in combination with agents like fluorouracil, oxaliplatin, and targeted biologics such as anti-VEGF (Bevacizumab). These combinations improve overall survival rates, incentivizing wider adoption [3].

3. Pipeline Innovations and New Indications
   Research into novel formulations and delivery mechanisms (e.g., liposomal irinotecan) extends therapeutic applications, potentially broadening market scope. FDA approvals for new indications, such as metastatic pancreatic cancer, augment its commercial viability.

4. Patent Landscape and Market Exclusivity
   While Pfizer's original patents expired in many regions, the transition to generic manufacturing has intensified price competition. Nonetheless, formulation patents for modified-release versions or combination regimens sometimes afford temporary market exclusivity.

Market Challenges

1. Generic Competition and Price Erosion
   Post-patent expiry, generic versions have significantly reduced treatment costs. Many regions now predominantly use generics, diluting revenue for originator firms and leading to downward pricing pressures.

2. Regulatory and Safety Concerns
   Irinotecan's toxicity profile, including risks of neutropenia and diarrhea, necessitates careful management. Advances in personalized medicine and targeted therapies are challenging traditional chemo agents' dominance.

3. Emergence of Targeted and Immunotherapies
   Checkpoint inhibitors and targeted biologics have gained prominence, often replacing or augmenting traditional chemotherapy. Their efficacy in certain patient subsets may diminish reliance on irinotecan.

4. Manufacturing and Supply Chain Complexities
   As with many chemotherapeutic agents, manufacturing complexities can impact supply, especially as regulatory scrutiny intensifies and quality standards evolve.

Financial Trajectory Analysis

The financial outlook for irinotecan hydrochloride hinges on several intertwined factors:

• Market Penetration in Key Regions: North America and Europe currently dominate sales, with growing markets historically in Asia-Pacific, driven by rising cancer burdens.

• Revenue Trends Post-Patent Expiry: Pfizer’s Camptosar lost patent protection in multiple jurisdictions around 2008-2010, leading to a substantial decline in revenue from the branded drug. Nonetheless, the presence of patents on specific formulations and combination drugs can sustain revenue streams temporarily.

• Impact of Biosimilars and Generics: The advent of generics has led to price reductions of up to 80% in some markets. For instance, in Europe, generic irintecan sales quickly surpassed branded prescriptions, leading to margin compression for originators [4].

• Emergence of Innovative Formulations: Liposomal irinotecan (e.g., Onivyde by Merrimack Pharmaceuticals, now owned by Ipsen) represents a lucrative sub-market, with FDA approval in metastatic pancreatic cancer. This formulation offers improved pharmacokinetics, allowing a premium pricing model and expanding indications.

• Future Market Growth Factors: The consummation of new indications, such as combination regimens approved for third-line treatments, and the development of predictive biomarkers may stabilize or boost demand. However, the competition from immuno-oncology agents could limit growth in traditional chemotherapy segments.

• Competitive Pricing and Reimbursement Dynamics: Healthcare payers' increasing emphasis on cost-effectiveness and the advent of value-based pricing models influence revenue forecasts. Countries adopting strict health technology assessments (HTA) may restrict reimbursement, reducing market potential.

Forecasting and Market Evolution

Over the next five years, the global irinotecan market is expected to decline in revenue terms within mature markets primarily due to generic competition. Nonetheless, specialized formulations such as liposomal irinotecan are anticipated to sustain higher-than-average margins owing to targeted indications and premium pricing.

Emerging markets, including China, India, and Brazil, are likely to be significant growth regions owing to expanding cancer treatment infrastructures and increasing cancer incidence. Agreements with local manufacturers and patent strategies for combination therapies could further modulate revenues.

Strategic Market Opportunities

• Development of Biosimilars and Generics: Manufacturers can focus on cost-effective generic production, expanding accessibility while maintaining margins through efficient manufacturing.

• Focus on Combination Therapies: Partnering with biologics or targeted therapies to develop integrated treatment regimens could enhance market share.

• Expansion into New Indications: Investing in clinical trials to identify new therapeutic niches for irinotecan derivatives remains critical.

• Innovative Delivery Systems: Advancing formulations that improve safety and efficacy, such as microsphere implants or targeted delivery, could command premium pricing.

Conclusion

The market dynamics for irinotecan hydrochloride are characterized by a combination of declining revenues in mature markets due to patent expiries and fierce generic competition, offset by opportunities in specialized formulations, new indications, and emerging markets. The financial trajectory remains cautiously optimistic for firms investing in innovative derivatives or combination therapies but is increasingly challenged by the rapid rise of targeted and immunotherapies in oncology.

Key Takeaways

• The global irinotecan hydrochloride market faces significant pressure from generics following patent expirations but retains opportunities through specialized formulations like liposomal irinotecan.

• Clinical advancements and combination regimens continue to sustain and expand its application in oncology.

• Market growth will be driven heavily by emerging economies, increased adoption of personalized medicine, and pipeline innovations.

• Firms should focus on differentiation strategies, including developing new formulations and expanding indications, to improve longevity and profitability.

• Competitive pricing, strategic partnerships, and investment in biosimilar development are essential to succeed amid evolving regulatory and reimbursement landscapes.

FAQs

1. What is the primary clinical use of irinotecan hydrochloride?
   It is predominantly used to treat metastatic colorectal cancer, often in combination with other chemotherapeutic agents. It also has roles in lung, pancreatic, and gastric cancers.

2. How has patent expiration impacted the irinotecan market?
   Patent expiry has led to the proliferation of generic versions, significantly reducing prices and revenues for original branded formulations, shifting market share towards cost-effective generics.

3. What are the emerging formulations of irinotecan?
   Liposomal irinotecan (e.g., Onivyde) offers improved pharmacokinetics and is approved for metastatic pancreatic cancer, opening new therapeutic avenues.

4. Are targeted therapies replacing irinotecan?
   While targeted therapies and immunotherapies are gaining prominence, irinotecan remains a cornerstone in combination chemotherapies for certain cancer types, particularly where targeted options are limited.

5. What is the future outlook for irinotecan in oncology?
   The outlook is shaped by innovation in drug delivery, expanding indications, and emerging markets, but faces challenges from newer targeted agents and immunotherapies affecting its market share.

---

References

[1] World Health Organization. Global Cancer Observatory.
[2] American Cancer Society. Cancer Facts & Figures 2022.
[3] Mayer, R. J., et al. "Initial report of a phase III trial of irinotecan combined with fluorouracil vs. fluorouracil alone as first-line treatment for metastatic colorectal cancer." Journal of Clinical Oncology 21.1 (2003): 151-157.
[4] IQVIA. “Impact of Generic Entry on Oncology Drug Markets.” 2021.