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Last Updated: December 22, 2024

IRINOTECAN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Irinotecan Hydrochloride, and what generic alternatives are available?

Irinotecan Hydrochloride is a drug marketed by 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-six NDAs.

The generic ingredient in IRINOTECAN HYDROCHLORIDE 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 Irinotecan Hydrochloride

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

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Drug patent expirations by year for IRINOTECAN HYDROCHLORIDE
Recent Clinical Trials for IRINOTECAN HYDROCHLORIDE

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

SponsorPhase
Oncotelic Inc.Phase 2/Phase 3
State University of New York - Downstate Medical CenterPhase 1/Phase 2
Harbin Medical UniversityPhase 2

See all IRINOTECAN HYDROCHLORIDE clinical trials

Pharmacology for IRINOTECAN HYDROCHLORIDE
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase Inhibitors
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
Qilu Pharm Hainan IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380-003 May 3, 2016 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078796-001 Feb 27, 2008 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharma Global IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078805-001 Apr 21, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090137-002 Nov 12, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharma Global IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078805-002 Apr 21, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
West-ward Pharms Int IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078753-002 Dec 24, 2008 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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]

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