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Last Updated: April 1, 2025

AMIFOSTINE Drug Patent Profile


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When do Amifostine patents expire, and when can generic versions of Amifostine launch?

Amifostine is a drug marketed by Eugia Pharma Speclts and Sun Pharm and is included in two NDAs.

The generic ingredient in AMIFOSTINE is amifostine. There are six drug master file entries for this compound. Additional details are available on the amifostine profile page.

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Drug patent expirations by year for AMIFOSTINE
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Recent Clinical Trials for AMIFOSTINE

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SponsorPhase
Institut du Cancer de Montpellier - Val d'AurellePhase 3
Tata Memorial CentrePhase 3
British Columbia Cancer AgencyPhase 2/Phase 3

See all AMIFOSTINE clinical trials

Medical Subject Heading (MeSH) Categories for AMIFOSTINE
Paragraph IV (Patent) Challenges for AMIFOSTINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ETHYOL For Injection amifostine 500 mg/vial 020221 1 2004-04-16

US Patents and Regulatory Information for AMIFOSTINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sun Pharm AMIFOSTINE amifostine INJECTABLE;INJECTION 077126-001 Mar 14, 2008 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma Speclts AMIFOSTINE amifostine INJECTABLE;INJECTION 204363-001 Jul 17, 2017 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Amifostine

Introduction to Amifostine

Amifostine is a cytoprotective agent used primarily to reduce the incidence of neutropenia-related fever and infection induced by chemotherapy, and to decrease the cumulative kidney damage caused by platinum-containing chemotherapy. It is also used to reduce the incidence of moderate to severe xerostomia (dry mouth) in patients undergoing radiotherapy for head and neck cancer.

Global Market Size and Growth

The global Amifostine market has been steadily growing, driven by increasing demand for cancer treatments and the need for protective agents against chemotherapy and radiotherapy side effects. As of 2021, the global Amifostine market size was estimated to be worth US$ 50 million. It is forecast to reach a readjusted size of US$ 58 million by 2030, with a Compound Annual Growth Rate (CAGR) of 2.1% during the forecast period of 2022-2030[1][4].

Market Segmentation

By Type

The Amifostine market is segmented by dose, primarily into 400mg/Dose and 500mg/Dose. These different dosages cater to various patient needs and treatment protocols[1][4].

By Application

The primary applications of Amifostine include:

  • Head and Neck Cancer Adjuvant Therapy: Amifostine is widely used to protect against the side effects of radiotherapy and chemotherapy in head and neck cancer patients.
  • Ovarian Cancer Adjuvant Therapy: It is also used in the treatment of ovarian cancer to mitigate the side effects of chemotherapy.
  • Other Applications: Amifostine may be used in other cancer treatments where cytoprotection is necessary[1][4].

Key Players and Competitive Landscape

The Amifostine market is dominated by several key players, including:

  • Clinigen Group
  • Sun Pharmaceutical
  • Taj Pharmaceuticals
  • Merro Pharmaceutical
  • Luye Pharma
  • Mingren Pharma

These companies employ various strategies to maintain their market positions, including product development, strategic partnerships, and competitive pricing[1][4].

Clinical and Economic Benefits

Amifostine has been shown to offer significant clinical and economic benefits. In a randomized phase II trial, patients receiving Amifostine had fewer episodes of severe side effects such as thrombocytopenia, mucositis, and xerostomia compared to the control group. This resulted in lower supportive care costs, including costs for infection management, blood cell support, alimentation, and hospitalization. The mean per patient supportive care costs were $4,401 for the Amifostine group versus $5,873 for the control group[2].

Market Drivers

Several factors drive the growth of the Amifostine market:

  • Increasing Cancer Cases: The rising incidence of cancer globally increases the demand for chemotherapy and radiotherapy, which in turn drives the need for protective agents like Amifostine.
  • Advancements in Cancer Treatment: Improvements in cancer treatment protocols and the integration of Amifostine into these protocols enhance its market demand.
  • Economic and Clinical Benefits: The cost savings and reduced side effects associated with Amifostine use make it an attractive option for healthcare providers and patients[1][2].

Market Challenges

Despite the growth potential, the Amifostine market faces several challenges:

  • Supply Chain Issues: The pharmaceutical industry, including Amifostine manufacturers, often struggles with supply chain disruptions due to factors like natural disasters, geopolitical issues, and economic constraints. These disruptions can lead to shortages and volatility in the market[3].
  • Fixed-Price Agreements: Insurance companies and pharmacy benefit managers often negotiate fixed-price agreements with drug manufacturers, which can keep prices depressed and reduce incentives for manufacturers to invest in robust supply chains[3].
  • Regulatory and Economic Pressures: Manufacturers may discontinue products if they are not profitable, and the lack of transparency in manufacturing costs and supply chain resilience can exacerbate these issues[3].

Regional Analysis

The Amifostine market is analyzed across various regions, including North America, Europe, Asia-Pacific, and others. Each region has its own demand and supply dynamics, influenced by local healthcare policies, economic conditions, and the prevalence of cancer. For instance, regions with higher cancer incidence rates tend to have higher demand for Amifostine[1][4].

Financial Projections and Revenue

The financial trajectory of the Amifostine market is characterized by steady growth. The market is expected to generate significant revenue, with projected values reaching US$ 58 million by 2030. The revenue growth is driven by increasing adoption in various cancer treatment protocols and the expanding patient base requiring cytoprotective agents[1][4].

SWOT Analysis

Strengths

  • Clinical Efficacy: Amifostine has proven clinical benefits in reducing the side effects of chemotherapy and radiotherapy.
  • Market Demand: Increasing cancer cases and advancements in cancer treatments drive the demand for Amifostine.
  • Competitive Landscape: The presence of multiple key players ensures a competitive market with various product offerings.

Weaknesses

  • Supply Chain Vulnerabilities: The market is susceptible to supply chain disruptions and shortages.
  • Economic Pressures: Fixed-price agreements and lack of profitability can lead to product discontinuation.
  • Regulatory Challenges: Transparency issues and regulatory pressures can affect market dynamics.

Opportunities

  • Expanding Applications: Potential use in other cancer treatments and medical conditions.
  • Market Expansion: Growing demand in emerging markets and regions.
  • Innovative Manufacturing: Investing in robust and resilient supply chains.

Threats

  • Competition from Alternatives: Emergence of alternative cytoprotective agents.
  • Economic Downturns: Economic instability affecting healthcare spending.
  • Regulatory Changes: Changes in healthcare policies and regulations impacting market dynamics.

Key Takeaways

  • The global Amifostine market is projected to grow from US$ 50 million in 2021 to US$ 58 million by 2030.
  • The market is driven by increasing cancer cases and the need for cytoprotective agents.
  • Key players include Clinigen Group, Sun Pharmaceutical, and others.
  • Amifostine offers significant clinical and economic benefits by reducing side effects and supportive care costs.
  • The market faces challenges such as supply chain disruptions and economic pressures.

FAQs

What is the primary use of Amifostine?

Amifostine is primarily used to reduce the incidence of neutropenia-related fever and infection induced by chemotherapy and to decrease the cumulative kidney damage caused by platinum-containing chemotherapy. It is also used to reduce the incidence of moderate to severe xerostomia in patients undergoing radiotherapy for head and neck cancer.

Which companies are the key players in the Amifostine market?

The key players in the Amifostine market include Clinigen Group, Sun Pharmaceutical, Taj Pharmaceuticals, Merro Pharmaceutical, Luye Pharma, and Mingren Pharma.

What are the main drivers of the Amifostine market?

The main drivers include increasing cancer cases, advancements in cancer treatment protocols, and the economic and clinical benefits associated with Amifostine use.

What challenges does the Amifostine market face?

The market faces challenges such as supply chain disruptions, fixed-price agreements, and economic pressures that can lead to product discontinuation and reduced investment in robust supply chains.

What is the projected growth rate of the Amifostine market?

The Amifostine market is forecast to grow at a CAGR of 2.1% from 2022 to 2030.

How does Amifostine impact supportive care costs?

Amifostine significantly reduces supportive care costs by minimizing the need for resources related to infection management, blood cell support, alimentation, and hospitalization, resulting in lower overall costs compared to control groups.

Sources

  1. Biospace: Amifostine Market Size, Growth, Trends, Forecast Report 2022-2030.
  2. PubMed: Economic analysis of amifostine as adjunctive support for patients receiving radiochemotherapy.
  3. NBC New York: Prescription drug shortages haven't gone away.
  4. Valuates Reports: Amifostine Hydrate - Market, Report Size, Worth, Revenue, Growth.

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