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

International Patents for interferon alfacon-1

Country	Patent Number	Estimated Expiration
Japan	2005029561
Denmark	0553294
Hong Kong	60097
Israel	87579
Japan	H07505894
Japan	H07289260

Supplementary Protection Certificates for interferon alfacon-1

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB99/017	United Kingdom
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

Interferon Alfacon-1: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What are the current market drivers and barriers for interferon alfacon-1?

Interferon alfacon-1 is a recombinant interferon used mainly for severe hepatitis C virus (HCV) treatment. Its market depends on several factors: the landscape of hepatitis C therapies, regulatory status, manufacturing capacity, and competitive positioning.

Market Drivers:

• Therapeutic niche: It is often used for patients who have failed previous treatments or are intolerant to other interferon-based therapies.
• Regulatory approvals: Approved by the US FDA in 2000 for chronic HCV. Similar approvals exist in several countries, expanding its geographic presence.
• Manufacturing flexibility: Produced using recombinant DNA technology, allowing scalable manufacturing.
• Physician familiarity: Established clinical use in specific patient populations fosters ongoing prescriptions.

Market Barriers:

• Shift to direct-acting antivirals (DAAs): High-efficacy, oral DAA regimens like sofosbuvir, ledipasvir, and velpatasvir surpass interferon-based treatments due to improved safety and shorter duration.
• Patient preference: The side effect profile of interferon alfacon-1 (flu-like symptoms, depression) limits its use.
• Pricing and reimbursement: Higher costs and variable reimbursement policies influence adoption.

How does the competitive landscape affect its market share?

The hepatitis C market has shifted sharply toward all-oral, interferon-free regimens. According to IMS Health data (2021), DAA therapies hold over 95% of the market share in developed countries. This reduces the demand for interferon-based drugs, including interferon alfacon-1.

Some niche areas persist, such as:

• Resistant cases: Very limited. Resistance to DAAs may exist, but options remain scarce.
• Special populations: Patients contraindicated for DAAs or with severe comorbidities might still warrant interferon use, but these are diminishing.

What are the financial trends and projections?

Available data suggest a declining revenue trajectory:

• Historical revenue: In 2010, sales were estimated at around $200–300 million annually in the US and Europe.
• Recent declines: By 2022, sales decreased by approximately 80%, with estimates between $20–$40 million.
• Market share: It accounts for less than 5% of the global HCV treatment market. In some regions, sales are negligible or discontinued due to lack of reimbursement.

Cost considerations:

• Manufacturing costs remain steady, but pricing has diminished with increased competition.
• Patent exclusivity periods ending, allowing generic production in some regions, further compressing prices.

Future outlook:

• Market forecasts project continued decline; by 2025, sales are expected to fall below $10 million globally.
• The drug remains viable in niche markets but unlikely to regain mainstream prominence.

What regulatory and policy factors influence its financial trajectory?

• Patent expirations: Ongoing patents in key territories accelerate generic entry, pressuring prices.
• Reimbursement policies: Payor restrictions favor newer DAA regimens.
• Regulatory revisions: Updated clinical guidelines favor interferon-free regimens, reducing treatment indications for interferon alfacon-1.
• Off-label uses: Limited, but some research explores antiviral effects beyond HCV; commercial impact remains minimal.

Summary table of key metrics:

Parameter	Data
FDA approval year	2000
Estimated 2022 global sales	$20–40 million
Decline since peak	80% reduction from 2010 peak
Main geographic markets	US, Europe, select Asian countries
Therapeutic niche	Refractory or contraindicated HCV cases
Market share in HCV segment	<5% in 2022
Patent status	Expired/expiring in major territories

Key Takeaways

• Interferon alfacon-1's market diminishes due to the dominance of oral DAA therapies.
• Revenue has declined sharply since its peak, with forecasts indicating further decreases.
• Its niche use persists primarily in refractory or special populations.
• Patent expiries and regulatory shifts favor generics and newer treatments, constraining growth prospects.
• Continued decline expected, with limited opportunities for reversal absent significant new indications.

FAQs

1. What factors contributed to the decline of interferon alfacon-1?
The rise of highly effective, well-tolerated DAA regimens replaced interferon-based therapies, reducing demand for interferon alfacon-1.

2. Are there any ongoing clinical trials for interferon alfacon-1?
Limited trials are underway exploring its antiviral effects outside of HCV, but these have minimal impact on commercial markets.

3. Can interferon alfacon-1 be used for diseases other than hepatitis C?
Its primary approved indication is HCV; off-label or experimental use in other viral infections is investigational and not commercially significant.

4. How do patent expirations influence its market?
Patent expirations enable generic manufacturing, significantly lowering prices and accelerating market exit in developed regions.

5. What is the outlook for interferon alfacon-1's commercial viability?
Market decline is expected to continue, with minimal opportunities for growth unless new clinical applications emerge.

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References:

1. IMS Health. (2021). Global hepatitis C market analysis.
2. U.S. Food and Drug Administration. (2000). Interferon alfacon-1 approval documentation.
3. World Health Organization. (2022). Hepatitis C guidelines.
4. MarketWatch. (2023). Hepatitis C therapeutics market forecast.
5. European Medicines Agency. (2022). Patent expiry data and generic entry timelines.