IRINOTECAN HYDROCHLORIDE - Generic Drug Details

What are the generic drug 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 Pharma Ltd, Hengrui Pharma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova, and is included in twenty-eight NDAs. There are nineteen 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 fifty-one patent family members in twenty-eight countries.

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

Summary for IRINOTECAN HYDROCHLORIDE

International Patents:	151
US Patents:	19
Tradenames:	3
Applicants:	25
NDAs:	28
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1,545
Patent Applications:	7,531
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
Oncotelic Inc.	Phase 2/Phase 3
State University of New York - Downstate Medical Center	Phase 1/Phase 2
Harbin Medical University	Phase 2

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
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes			Y	Y
Sandoz	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	077994-002	Feb 27, 2008		DISCN	No	No
Pliva Lachema	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	078122-002	Oct 31, 2008		DISCN	No	No
Sandoz	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	077994-001	Feb 27, 2008		DISCN	No	No
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes			Y	Y

Expired US Patents for IRINOTECAN HYDROCHLORIDE

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 IRINOTECAN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201717933	Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal IRINOTECAN and OXALIPLATIN
Japan	2017149783	リポソームイリノテカンを含む併用療法を用いた、膵臓癌を治療するための方法 (METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOME IRINOTECAN)
Hong Kong	1258722	穩定喜樹碱藥物組合物 (STABILIZING CAMPTOTHECIN PHARMACEUTICAL COMPOSITIONS)
Portugal	3266456
Russian Federation	2574926	ЛИПОСОМНЫЕ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМЫЕ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ (LIPOSOMAL COMPOSITIONS APPLICABLE FOR DRUG DELIVERY)

Supplementary Protection Certificates for IRINOTECAN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
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
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	1790033-3	Sweden		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008

IRINOTECAN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Irinotecan Hydrochloride

Introduction

Irinotecan hydrochloride, a potent chemotherapeutic agent, is widely used in the treatment of various types of cancer, particularly colorectal cancer. The market for irinotecan hydrochloride is influenced by a complex interplay of factors, including increasing cancer incidence, advancements in medical technology, and regulatory environments.

Market Size and Growth Projections

The global irinotecan market has demonstrated significant growth and is expected to continue this trend. As of 2023, the market size was valued at approximately USD 9.2 billion[4].

• Growth Rate: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.1% from 2023 to 2033[3].
• Forecast Period: By 2031, the irinotecan hydrochloride injection market is anticipated to achieve substantial growth, driven by increasing demand and advancements in cancer treatment methodologies[1].

Key Drivers of Market Growth

Several factors are driving the growth of the irinotecan hydrochloride market:

Rising Incidence of Cancer

The global rise in cancer cases, especially colorectal cancer, is a major driver. According to the World Health Organization (WHO), colon cancer is the second leading cause of cancer-related deaths globally, and the burden of colorectal cancer is expected to increase by 63% by 2040[3].

Advancements in Cancer Treatment

Breakthroughs in colorectal cancer diagnosis and treatment, along with increased awareness among patients and healthcare professionals, have supported market growth. Innovations in targeted therapies, immunotherapies, and precision medicine are also contributing to the market's expansion[3].

Aging Population

The aging population, particularly in regions like North America and Asia-Pacific, is more prone to cancer, thereby increasing the demand for irinotecan hydrochloride[4].

Regulatory Approvals

Gaining regulatory approvals for irinotecan-based treatments and increased research into new uses are significant motivators for market growth[4].

Market Segmentation

The irinotecan hydrochloride market is segmented based on several criteria:

By Type

• Irinotecan Hydrochloride Injection 40mg: This segment accounted for the largest market share in 2023, due to its widespread use in treating various types of cancer[3].
• Irinotecan Hydrochloride Injection 100mg: This segment also holds a significant share, driven by its efficacy in advanced cancer treatments[1].

By Application

• Clinic: Clinics are a major application area, given the outpatient nature of many cancer treatments.
• Hospital: Hospitals also play a crucial role, especially for more complex and advanced cancer treatments[1].

By Geography

• North America: Dominated the market in 2023 with over 38% of global revenue, driven by a strong healthcare system, significant investments in pharmaceutical R&D, and a high incidence of cancer[4].
• Asia-Pacific: This region is growing rapidly due to a large and aging population, rising cancer cases, cost-effective manufacturing, and improved healthcare infrastructure[4].
• Europe, Latin America, and Middle East & Africa: These regions also contribute to the market growth, albeit at a slower pace compared to North America and Asia-Pacific[4].

Market Restraints

Despite the growth drivers, the irinotecan hydrochloride market faces several restraints:

Generic Competition

Generic competition and pricing pressures significantly impact the market, affecting both patients and manufacturers. The availability of generic versions of irinotecan hydrochloride can reduce the market share of branded products[4].

Adverse Effects

The drug's side effects, such as severe diarrhea and neutropenia, can limit its adoption and affect patient compliance[5].

Regulatory Hurdles

Evolving regulatory environments and the need for continuous approvals can pose challenges to market growth[4].

Financial Trajectory

The financial performance of the irinotecan hydrochloride market is influenced by several factors:

Revenue

• The market revenue is expected to increase significantly over the forecast period, driven by the growing demand for cancer treatments and advancements in medical technology[1].

Key Players

Major players in the market include Pfizer, Teva, Actiza Pharmaceutical, Getwell, Taj Pharma, Cipla, Salius, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries Ltd. These companies invest heavily in R&D and have strong distribution networks, contributing to the market's financial stability[3].

Regional Performance

• North America's strong healthcare infrastructure and high cancer incidence contribute to its dominant market share. The region's well-defined reimbursement system and regulatory approvals further support the financial trajectory[4].

Technological Advancements and Innovations

The market is witnessing several technological advancements:

Targeted Therapies

The development of targeted therapies and immunotherapies is enhancing the efficacy of irinotecan hydrochloride and reducing side effects[3].

Precision Medicine

Advancements in precision medicine are allowing for more personalized treatment approaches, which is a significant growth opportunity for the market[4].

Drug Delivery Systems

Improvements in drug delivery systems are aimed at enhancing the drug's efficacy and reducing its adverse effects, which can further drive market growth[3].

Conclusion

The irinotecan hydrochloride market is poised for significant growth driven by the rising incidence of cancer, advancements in treatment methodologies, and regulatory approvals. However, the market must navigate challenges such as generic competition, adverse effects, and regulatory hurdles.

Key Takeaways

• The global irinotecan market is projected to grow at a CAGR of 6.1% from 2023 to 2033.
• North America and Asia-Pacific are the dominant regions due to their strong healthcare infrastructure and rising cancer incidence.
• The market is segmented by type, application, and geography, with irinotecan hydrochloride injection 40mg being the largest segment.
• Key players are investing heavily in R&D and distribution networks to maintain market share.
• Technological advancements in targeted therapies, precision medicine, and drug delivery systems are driving market growth.

FAQs

Q: What is the projected CAGR for the irinotecan hydrochloride market from 2023 to 2033?

A: The market is expected to grow at a CAGR of 6.1% from 2023 to 2033[3].

Q: Which region dominates the irinotecan hydrochloride market?

A: North America dominates the market, accounting for over 38% of global revenue in 2023[4].

Q: What are the main drivers of the irinotecan hydrochloride market?

A: The main drivers include the rising incidence of cancer, advancements in cancer treatment, and regulatory approvals[3][4].

Q: What are the significant restraints facing the irinotecan hydrochloride market?

A: Generic competition, adverse effects, and regulatory hurdles are significant restraints[4].

Q: Who are the major players in the irinotecan hydrochloride market?

A: Major players include Pfizer, Teva, Actiza Pharmaceutical, Getwell, Taj Pharma, Cipla, Salius, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries Ltd.[3].

Sources

1. Market Research Intellect - Irinotecan Hydrochloride Injection Market Size, Scope And Forecast[1]
2. Sanofi - Annual Report on Form 20-F[2]
3. Market Statsville Group - Irinotecan Market Size, Share and Trends Analysis by 2033[3]
4. Cognitive Market Research - Irinotecan Market Report[4]
5. FDA - N20-571S023 Irinotecan Clinpharm[5]