INFERGEN Drug Profile

Summary for Tradename: INFERGEN

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 company disclosures

These patents were identified from searching various sources, including 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 INFERGEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for INFERGEN 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 INFERGEN 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

International Patents for INFERGEN

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

Supplementary Protection Certificates for INFERGEN

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: INFERGEN

Last updated: September 26, 2025

Introduction

INFERGEN (alferon) is a recombinant interferon alfa-2a product developed for antiviral and oncological indications. Initially marketed by Novartis and subsequently by other pharmaceutical entities, its trajectory illustrates significant shifts influenced by evolving market dynamics, competitive landscapes, and regulatory considerations. This analysis provides a comprehensive overview of the market environment impacting INFERGEN's prospects, along with projections of its financial trajectory.

Historical Context and Product Overview

INFERGEN, a biologic interferon alfa-2a, was approved for indications such as hepatitis B and C and certain cancers. Its mechanism involves modulating immune response to combat viral infections and tumor growth. The drug entered the market in the early 1990s, a period when interferons represented a cornerstone in antiviral therapy, especially for hepatitis C (HCV) — a prevalent chronic infection.

The original introduction was characterized by robust demand driven by limited antiviral options. However, the landscape shifted markedly with the advent of direct-acting antivirals (DAAs), significantly altering INFERGEN's positioning.

Market Dynamics

1. Competition from Next-Generation Therapies

The entry of potent, oral, all-oral DAA regimens revolutionized HCV treatment, with cure rates exceeding 95% and markedly improved safety profiles [1]. These therapies, such as sofosbuvir-based combinations, rapidly rendered interferons like INFERGEN obsolete for HCV.

Moreover, in oncology, the rise of targeted agents and immune checkpoint inhibitors diminished reliance on interferons, relegating INFERGEN primarily to niche or off-label uses.

2. Regulatory and Patent Landscape

The patent expiration of INFERGEN in many jurisdictions weakened its market exclusivity. Although biologic products often enjoy longer exclusivity periods (up to 12 years in the U.S.), the rapid development and approval of biosimilars and generics pressured pricing and market share.

Additionally, regulatory agencies have imposed stricter safety and efficacy standards for biologic therapies, influencing the product's continued viability.

3. Market Size and Patient Population Trends

The global prevalence of hepatitis B and C remains substantial, with over 290 million people infected with hepatitis B and approximately 58 million with hepatitis C worldwide [2]. However, the introduction of DAAs has drastically reduced the demand for interferon-based therapies, limiting potential growth in these markets.

In oncology, the indications for INFERGEN are limited, leading to a contraction of target patient populations, further impacted by new immunotherapies.

4. Pricing and Reimbursement Policies

Healthcare systems worldwide have shifted toward cost-effective, highly efficacious treatments. The higher costs associated with biologics, combined with better alternatives, have led to reduced reimbursement and constrained access for older interferon therapies. Price erosion has become a significant concern, especially in markets with strict payor policies.

Financial Trajectory

1. Revenue Trends

Initially, INFERGEN demonstrated healthy revenue streams aligned with the height of interferon-based antiviral therapy demand. However, revenue diminished sharply post-2015, correlating with DAA introductions. For instance, Novartis reported declining sales in its interferon portfolio, including INFERGEN, highlighting the erosive impact of newer treatments.

2. R&D and Lifecycle Management

Despite the declining current revenues, some manufacturers have invested in biosimilar development to capitalize on existing manufacturing capabilities. The biosimilar versions of interferons have gained approval in several markets, further pressuring the original product’s market share.

Future Outlook and Market Opportunities

1. Niche and Off-Label Applications

While primary indications diminished, some research explores INFERGEN’s potential in treating other viral infections or as part of combination therapies. The unfurling of new evidence or unmet needs could unlock niche markets.

2. Biosimilar Competition

The global push towards biosimilar adoption offers opportunities for pharmaceutical companies to gain market share by offering more affordable alternatives. Companies like Biocon and Dr. Reddy’s have developed interferon biosimilars, which could further truncate INFERGEN's revenue.

3. Evolving Therapeutic Strategies

Emerging immunotherapies and personalized medicine approaches may redefine the biologic landscape, requiring INFERGEN to adapt through reformulation, combination strategies, or innovative indications.

Regulatory and Market Risks

• Patent cliffs threaten sustained exclusivity.
• Market entrance of biosimilars exerts downward pressure.
• Evolving clinical guidelines favor newer agents.
• Pricing pressures and reimbursement constraints challenge profitability.

Conclusion

The market dynamics have rendered INFERGEN's original positioning increasingly obsolete due to technological advancements, regulatory changes, and strategic shifts towards more effective therapies. The financial trajectory reflects a steep decline from peak revenues, with limited prospects for significant recovery without strategic repositioning ornovel indications.

Key Takeaways

• Market evolution: The rise of direct-acting antivirals has displaced interferons in hepatitis treatment, causing revenues to decline sharply.
• Competitive pressures: Biosimilars and generics further threaten the remaining market share.
• Strategic pivoting: Opportunities exist in niche indications or combination therapies, albeit with uncertain success.
• Regulatory landscape: Patent expiry and evolving standards impose additional hurdles.
• Future prospects: Success depends on innovation, diversification, and adaptation to evolving therapeutic paradigms.

---

FAQs

1. What is the primary reason for INFERGEN’s decline in the market?
The primary driver is the advent of direct-acting antivirals, which offer higher cure rates, shorter treatment durations, and better safety profiles, replacing interferon-based therapies like INFERGEN.

2. Are there any new therapeutic uses being explored for INFERGEN?
Research is limited but includes exploring its utility in combination therapies or for niche viral infections. However, no widespread new applications have been established recently.

3. How do biosimilars impact INFERGEN’s market share?
Biosimilars introduce lower-cost alternatives, drastically reducing pricing power and leading to product displacement in regulated markets.

4. Can INFERGEN regain market relevance?
Unlikely unless it is repurposed for unmet medical needs or develops innovative formulations, given the dominance of newer therapies and biosimilars.

5. What strategies should manufacturers consider for biologics like INFERGEN amidst declining revenues?
Investing in biosimilar development, seeking novel indications, or licensing agreements can mitigate revenue decline and leverage manufacturing expertise.

---

References

[1] Feld, J. J., et al. (2016). "Sofosbuvir-based regimens for hepatitis C virus infection." The New England Journal of Medicine, 375(10), 1005-1017.
[2] World Health Organization. (2020). "Global hepatitis report".