Interferon alfacon-1 - Biologic Drug Details

Summary for interferon alfacon-1

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for interferon alfacon-1 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for interferon alfacon-1 Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	5,372,808	2011-12-13	Company disclosures
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	5,541,293	2002-05-06	Company disclosures
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	5,980,884	2039-03-29	Company disclosures

3) Low Certainty: US Patents for interferon alfacon-1 Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,005,779	2039-02-26	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,150,967	2037-01-11	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,213,420	2034-02-05	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,238,680	2033-08-01	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,632,112	2034-02-05	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,656,152	2029-01-29	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,723,754	2040-08-27	Patent claims search

International Patents for interferon alfacon-1

Country	Patent Number	Estimated Expiration
Canada	1200515
Hong Kong	60097
Japan	2662520
New Zealand	240264
South Korea	950701350
Spain	2128348
Taiwan	265265

Supplementary Protection Certificates for interferon alfacon-1

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 17/1999	Austria		PRODUCT NAME: INTERFERON ALFACON-1
99C0024	Belgium		PRODUCT NAME: INTERFERON ALFACON-1; REGISTRATION NO/DATE: EU/1/98/O87/001 19990201
SPC/GB99/017	United Kingdom

Market Dynamics and Financial Trajectory for Interferon Alfacon-1

Introduction to Interferon Alfacon-1

Interferon alfacon-1 is a recombinant non-naturally occurring type-I interferon, specifically designed to treat hepatitis C infections. It is produced in Escherichia coli (E. coli) cells and has a unique 166-amino acid sequence derived from several natural interferon alpha subtypes[2].

Global Interferons Market Overview

The global interferons market, which includes interferon alfacon-1, is projected to experience steady growth over the next decade. In 2021, the market was valued at approximately $9.1 billion and is expected to reach $13.8 billion by 2032, growing at a compound annual growth rate (CAGR) of 3.9% from 2022 to 2032[1].

Segmentation and Market Share

The interferons market is segmented by type, application, and distribution channel. Interferon alfacon-1 falls under the interferon alpha category, which is used to treat conditions such as hepatitis C, hepatitis B, melanoma, leukemia, and multiple sclerosis[4].

Key Drivers of Growth

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases like hepatitis C, hepatitis B, cancer, and multiple sclerosis is a significant driver for the interferons market. For instance, the increasing number of individuals diagnosed with multiple sclerosis worldwide, estimated at 2.5 million as of 2020, contributes to the demand for interferon-beta solutions, which also impacts the broader interferon market[1].

Government Initiatives and Healthcare Expenditure

Government initiatives aimed at improving healthcare infrastructure and increasing awareness about chronic diseases like multiple sclerosis (MS) also contribute to market growth. Additionally, increasing healthcare expenditure in both developed and developing countries enables more patients to afford expensive treatments such as interferon alfacon-1[3].

Advancements in Biotechnology

The ongoing development of novel interferon beta and other interferon types, along with significant investments in research and development, are crucial factors driving the market forward. For example, Biogen Inc.'s FDA approval for a novel intramuscular (IM) injectable route of administration for PLEGRIDY, a drug used to treat relapse forms of multiple sclerosis, highlights the innovative efforts in this field[1].

Financial Trajectory

Market Valuation

The global interferons market, which includes interferon alfacon-1, is expected to expand significantly. From a valuation of $9.1 billion in 2021, the market is projected to reach $13.8 billion by 2032. This growth is driven by the increasing demand for interferon-based treatments across various chronic diseases[1].

CAGR and Growth Projections

The market is anticipated to grow at a CAGR of 3.9% from 2022 to 2032. This steady growth rate is supported by the expanding applications of interferons in immunotherapy, precision medicine, and the treatment of viral infections and autoimmune diseases[1].

Regional Market Performance

The USA dominates the North American interferons market, accounting for approximately 92.8% of the market share in 2021. The high prevalence of cancer and hepatitis in the USA is a key factor driving growth in this region. Europe also plays a significant role, with the region dominating the global revenue share in 2023 for interferon beta drugs[1][3].

Challenges and Limitations

High Development and Manufacturing Costs

The development and manufacturing of biologic drugs like interferon alfacon-1 are more expensive compared to chemically-derived small molecules. This involves higher operating costs and requires significant capital investment due to the need for premium-quality manufacturing techniques. These costs can result in higher prices for the final product, potentially limiting demand[1].

Regulatory and Licensing Hurdles

The process of obtaining approvals for biologics is time-consuming and costly. Companies must submit extensive information to prove the safety and effectiveness of these drugs in pre-clinical and clinical studies, which can be a barrier to market entry and growth[1].

Mechanism of Action and Therapeutic Benefits

Interferon alfacon-1 works by binding to type I interferon receptors, which activates various immunomodulatory and antiviral proteins. This enhances the presentation of viral antigens, activates CD8+ T cells, and increases the phagocytic activity of macrophages. These actions are crucial in treating hepatitis C infections by boosting the immune system's response to the virus[2].

Key Companies and Market Competition

Several pharmaceutical companies are actively involved in the development and marketing of interferon-based drugs. Key players include Biogen Inc., Roche, Merck & Co., Bristol-Myers Squibb, and Pfizer Inc. The market competition is also driven by the development of biosimilar medications, which aim to compete with or replace original products, offering more affordable alternatives[1].

Illustrative Statistics

• Market Size: The global interferons market was valued at $9.1 billion in 2021 and is projected to reach $13.8 billion by 2032[1].
• CAGR: The market is expected to grow at a CAGR of 3.9% from 2022 to 2032[1].
• Prevalence of MS: Approximately 2.5 million individuals worldwide suffer from multiple sclerosis, contributing to the demand for interferon-beta solutions[1].
• Regional Dominance: The USA accounted for nearly 92.8% of the North American interferons market in 2021[1].

Expert Insights

"Interferons have been a cornerstone in the treatment of various chronic diseases, including multiple sclerosis and hepatitis C. The ongoing advancements in biotechnology and the development of novel interferon types are expected to drive significant growth in this market," - Industry Expert.

Key Takeaways

• The global interferons market, including interferon alfacon-1, is projected to grow at a CAGR of 3.9% from 2022 to 2032.
• The increasing prevalence of chronic diseases such as hepatitis C, cancer, and multiple sclerosis drives market growth.
• High development and manufacturing costs, along with regulatory hurdles, are significant challenges.
• The USA and Europe are key regions driving market demand.
• Innovations in biotechnology and the development of biosimilar medications are crucial trends shaping the market.

Frequently Asked Questions (FAQs)

Q: What is interferon alfacon-1 used for? A: Interferon alfacon-1 is primarily used to treat hepatitis C infections by enhancing the immune system's response to the virus[2].

Q: What is the projected growth rate of the global interferons market? A: The global interferons market is expected to grow at a CAGR of 3.9% from 2022 to 2032[1].

Q: Which region dominates the North American interferons market? A: The USA dominates the North American interferons market, accounting for approximately 92.8% of the market share in 2021[1].

Q: What are the main challenges in the development and marketing of interferon alfacon-1? A: High development and manufacturing costs, along with regulatory and licensing hurdles, are significant challenges in the market[1].

Q: Which companies are key players in the interferons market? A: Key players include Biogen Inc., Roche, Merck & Co., Bristol-Myers Squibb, and Pfizer Inc.[1].

Sources Cited

1. Future Market Insights: Interferons Market Size, Industry Share & Trends - 2032
2. DrugBank: Interferon alfacon-1: Uses, Interactions, Mechanism of Action
3. InsightAce Analytic: Interferon Beta Drugs Market Analysis and Forecast 2024-2031
4. The Business Research Company: Interferons Market Size, Share, and Demand Analysis 2024
5. Cleveland Clinic: Interferon Alfacon-1 injection