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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and 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	2012-04-15	DrugPatentWatch analysis and company disclosures
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	5,541,293	2010-01-30	DrugPatentWatch analysis and company disclosures
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	5,980,884	2016-02-05	DrugPatentWatch analysis and 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	2034-06-04	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	2036-10-04	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,238,680	2035-11-30	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,632,112	2038-12-28	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,656,152	2037-11-08	Patent claims search
Kadmon Pharmaceuticals Llc	INFERGEN	interferon alfacon-1	Injection	103663	10,723,754	2033-10-21	Patent claims search

International Patents for interferon alfacon-1

Country	Patent Number	Estimated Expiration
Hungary	9900929
Hong Kong	60197
Canada	2118121
Canada	2094275
Mexico	9302160
Australia	9023591
Hong Kong	1018595

Supplementary Protection Certificates for interferon alfacon-1

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

Market Dynamics and Financial Trajectory for the Biologic Drug: Interferon Alfacon-1

Last updated: July 29, 2025

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Introduction

Interferon alfacon-1, marketed primarily under the brand name Infergen, represents a recombinant type I interferon used primarily in the treatment of chronic hepatitis C virus (HCV) infection. As a synthetic analog of natural interferons, it stimulates immune responses to suppress viral replication. The drug’s market performance, influenced by evolving treatment paradigms, regulatory pathways, and competitive dynamics, offers an insightful case study in the biopharmaceutical landscape.

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Pharmacological Profile and Clinical Positioning

Interferon alfacon-1 is a genetically engineered interferon expressed in Escherichia coli. Its mechanism involves activating antiviral pathways, immune modulation, and inhibition of viral protein synthesis. Historically, it served as an alternative to pegylated interferons, especially in patients intolerant to standard treatments.

Despite its efficacy, the drug’s clinical adoption waned with advances in direct-acting antivirals (DAAs), such as sofosbuvir and ledipasvir, which achieved higher cure rates, shorter treatment durations, and better tolerability.

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Market Dynamics

1. Therapeutic Shifts Driven by DAAs

The shift from interferon-based regimens to direct-acting antivirals has significantly reconfigured the HCV treatment landscape. DAAs exhibit cure rates exceeding 95% with minimal side effects, rendering interferon-based therapies largely obsolete in many jurisdictions.

This paradigm change has compressed the market for interferon alfacon-1, transforming it from a frontline antiviral agent into a niche or discontinued product in several markets. The decline in demand is reflected in reduced prescriptions, revenue downturns, and strategic repositioning by pharmaceutical companies.

2. Regulatory and Patent Considerations

Initially approved by the FDA in the early 2000s, interferon alfacon-1 faced patent expirations and limited new patent filings, further eroding market exclusivity. Regulatory agencies have also issued warnings or withdrawn approvals in some regions, citing dwindling clinical relevance and availability of superior therapies.

The regulatory environment thus acts as both a gatekeeper and a market shaper, influencing investment in further clinical development or line extensions.

3. Competitive Landscape

The emergence of interferon-free regimens has rendered interferon-based drugs less competitive. Biotech and pharma companies have shifted focus to newer, more profitable pipeline candidates, leading to decreased R&D in interferon derivatives.

Existing manufacturers may only maintain minimal production, primarily for niche indications, off-label uses, or research purposes, with some products phased out entirely.

4. Geographic and Market-Specific Dynamics

While global markets have largely transitioned away from interferon-based HCV treatments, certain regions with limited access to DAAs or delayed healthcare infrastructure adoption still utilize interferon therapies, including interferon alfacon-1. These regional disparities offer limited but enduring niche market opportunities.

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Financial Trajectory

1. Revenue Trends

The commercialization of interferon alfacon-1 experienced peak revenues in the early 2000s, coinciding with the onset of its clinical use. However, revenues declined steeply post-2010, aligned with the advent of potent DAAs. Many pharmaceutical companies reduced marketing efforts, and some discontinued manufacturing altogether.

An illustrative example: Schering-Plough (prior to its acquisition by Merck) reported declining sales of infergen post-2010, reflecting the global trend.

2. Research and Development Investments

Investment in R&D for interferon alfacon-1 diminished sharply following the DAA revolution. Limited ongoing clinical studies or line extension programs exist, indicating minimal pipeline activity and a focus on alternative therapeutic targets.

3. Market Exit and Strategic Repositioning

Most companies have exited or scaled back interferon-related activities. Some have repurposed production capacity for newer biologics or entirely different classes of medications.

Pharmaceutical firms have shifted focus toward personalized medicine, immuno-oncology, and regenerative therapies, relegating interferon-based drugs to historical relevance.

4. Potential Future Market Scenarios

Given the broad global decline, the future financial trajectory of interferon alfacon-1 remains subdued. Niche markets may sustain minimal revenues for research or humanitarian use, but large-scale profitability is unlikely.

However, regulatory or scientific breakthroughs could spawn new indications—such as antiviral or immunomodulatory applications—that might rekindle interest, although current evidence suggests this is improbable.

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Regulatory and Competitive Outlook

Regulatory Environment

Authorities like the FDA and EMA have streamlined approval pathways for newer biologics, often favoring innovations over non-patented or discontinued molecules like interferon alfacon-1. The lack of recent approvals or label updates indicates regulatory disfavor.

Competitive Pressures

The competitive landscape is dominated by oral DAAs, rendering injectable interferons largely obsolete in developed markets. The shift emphasizes efficacy, safety, patient convenience, and cost-effectiveness—areas where interferon alfacon-1 cannot compete.

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Implications for Industry Stakeholders

• Pharmaceutical Companies: Should consider divestment or licensing for niche uses; focus on pipeline innovation.
• Investors: Must recognize the deprecating value of historically significant but clinically outdated drugs.
• Regulatory Bodies: Continue streamlining access for new therapeutics, while phasing out obsolete drugs to optimize resource allocation.
• Healthcare Providers: Shift towards prescribing newer, more effective, and better-tolerated therapies.

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Key Takeaways

• The therapeutic landscape shift from interferon-based therapies to DAAs led to a steep decline in the market for interferon alfacon-1.
• Patent expirations, regulatory withdrawal, and a superior competitive set have decisively marginalized its use.
• Future prospects for interferon alfacon-1 are limited; any revenue generation prospects are primarily confined to regional or niche applications.
• Industry focus continues to pivot toward personalized, oral, and targeted therapies with higher efficacy and patient adherence profiles.
• Strategic planning should prioritize innovation and pipeline development aligned with current clinical standards and market demands.

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FAQs

Q1: Why did the market for interferon alfacon-1 decline so rapidly?
The advent of direct-acting antivirals (DAAs) with higher cure rates, shorter treatment durations, and fewer side effects rendered interferon therapies obsolete in the treatment of hepatitis C, drastically reducing demand.

Q2: Are there any ongoing clinical trials or new indications for interferon alfacon-1?
Current evidence indicates minimal to no ongoing development or new indications, with focus shifted to newer biologics and innovative therapies.

Q3: Can interferon alfacon-1 find a niche in regions with limited access to DAAs?
Potentially, yes. In countries with limited healthcare infrastructure or delayed adoption of new therapies, interferon-based treatments may persist, offering marginal market opportunities.

Q4: What are the main regulatory challenges facing interferon alfacon-1 today?
Regulatory agencies have largely deprioritized approval or renewal of indications for interferon alfacon-1, favoring newer treatments, leading to reduced market approval and accessibility.

Q5: What strategic advice should pharmaceutical stakeholders consider regarding interferon alfacon-1?
Stakeholders should evaluate licensing, licensing-out, or phased discontinuation, aligning portfolio strategies with current treatment standards while exploring innovative biologics with higher therapeutic value.

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References
[1] Schering-Plough. (2004). Infergen (interferon alfacon-1) Prescribing Information.
[2] Gilead Sciences. (2013). HCV Treatment Landscape Review.
[3] FDA. (2016). Drug Approvals and Withdrawals.
[4] World Health Organization. (2020). HCV Treatment Global Status.
[5] Market Research Future. (2021). Biologics Market Analysis.