INTRON A Drug Profile

Summary for Tradename: INTRON A

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for INTRON A

Recent Clinical Trials for INTRON A

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
RWTH Aachen University	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2
Roswell Park Cancer Institute	Phase 1/Phase 2

See all INTRON A clinical trials

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 INTRON A Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for INTRON A 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
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	4,496,537	2003-09-16	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	4,530,901	2000-02-04	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	5,766,582	2014-10-11	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	5,935,566	2018-06-12	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	6,610,830	2001-04-21	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	Injection	103132	4,496,537	2003-09-16	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	Injection	103132	4,530,901	2000-02-04	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for INTRON A 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
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,005,779	2034-06-04	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,016,338	2036-12-20	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,016,377	2037-08-23	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,016,412	2036-12-09	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,053,697	2036-01-08	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,066,269	2034-03-14	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	10,105,389	2037-03-31	Patent claims search

International Patents for INTRON A

Country	Patent Number	Estimated Expiration
Denmark	158771
Portugal	72322
South Korea	860001558
Finland	810030
European Patent Office	0211148
United Kingdom	2079291
Slovenia	8110026

Market Dynamics and Financial Trajectory for INTRON A (Interferon Alfa-2b)

Last updated: September 22, 2025

Introduction

INTRON A (interferon alfa-2b) represents a pivotal biologic therapeutic launched in the early 1980s, primarily indicated for various viral infections and certain cancers. Developed by Schering-Plough (now Merck), its legacy as a pioneer in immunotherapy profoundly influences current biologic markets. This analysis examines the evolving market landscape and anticipated financial trajectory of INTRON A, emphasizing technological shifts, regulatory factors, competitive pressures, and emerging therapeutic trends.

Market Dynamics

Historical Context and Established Market Position

Initially approved in 1986 for hairy cell leukemia, INTRON A’s indications expanded over decades to include hepatitis B and C, melanoma, and Kaposi's sarcoma. Its early adoption was driven by groundbreaking clinical results; however, its complex manufacturing process, injection-based administration, and adverse effects posed significant barriers.

Competitive Landscape and Evolving Therapeutics

In recent years, the biologic market has become crowded with alternative therapies. Specifically, for hepatitis C, direct-acting antivirals (DAAs)—led by products like Harvoni (ledipasvir/sofosbuvir)—have rendered interferons largely obsolete, relegating INTRON A primarily to niche indications or historical contexts. For melanoma, immune checkpoint inhibitors such as pembrolizumab and nivolumab now dominate, further diminishing interferon’s market share.

Regulatory and Reimbursement Dynamics

Regulatory agencies increasingly favor therapies with superior safety profiles and simplified administration. The advent of oral, targeted drugs has pressured reimbursement frameworks, reducing the economic attractiveness of interferon-based treatments. Nonetheless, INTRON A maintains approval in certain countries, especially where access to newer agents remains limited, and in specific oncology indications, including symptomatic management of some malignancies.

Technology and Manufacturing Challenges

Biologics like INTRON A require complex manufacturing involving recombinant DNA technology. Consistency, scalability, and cold-chain logistics influence supply stability and cost. Although biosimilars could threaten price points, no approved biosimilar interferon alfa-2b is currently significantly impacting the market, partly due to patent and regulatory considerations.

Emerging Trends and Future Opportunities

• Biosimilars and Patent Expirations: The expiration of key patents could introduce biosimilars, potentially reducing costs but also fragmenting markets.
• Combination Therapies: Integrating INTRON A with novel agents remains an area of interest, especially in oncology and viral infections.
• Precision Medicine: Identification of patient populations most likely to benefit from interferon therapy could rejuvenate its clinical relevance.

Financial Trajectory

Current Revenue Streams

While historical revenue for INTRON A reached hundreds of millions annually globally, current figures depict a sharp decline, notably for hepatitis indications. In 2021, global sales approximately ranged between $80 million to $100 million, with the majority derived from established markets like Europe and emerging regions.

Market Share and Segmentation

• Hepatitis C: The share has dwindled significantly due to DAAs, with annual sales now mostly from niche cases or regions without access to newer drugs.
• Oncology: Limited to selected cancer types; revenue remains stable but minimal relative to modern immunotherapies.
• Other Indications: Rare, with minimal financial contribution.

Growth Drivers and Challenges

• Growth Drivers: Potential increased adoption in regions with limited access to newer biologics, and strategic positioning within combination regimens.
• Challenges: Competition from newer biologics, declining demand for interferon-based treatments, and high manufacturing costs tend to suppress margins and growth potential.

Forecast and Investment Outlook

Industry forecasts predict a continued decline in INTRON A’s revenue over the next five years. However, niche applications and developing biosimilar markets could offer marginal growth. For pharmaceutical companies, investments in biosimilars or switching to adjacent therapeutic areas might prove more profitable than maintaining traditional interferon formulations.

Regulatory and Strategic Considerations

Regulators are increasingly emphasizing safety, efficacy, and patient quality-of-life metrics. INTRON A’s safety profile, characterized by flu-like symptoms and hematological side effects, limits its appeal. Strategic shifts involve:

• Consolidation or licensing agreements to exploit existing manufacturing infrastructure.
• Focus on rare or underserved indications where existing therapies underperform.
• Partnerships to develop combination treatments or biosimilars.

Conclusion

The biotech landscape governing INTRON A has undergone substantial transformation. Once a frontline therapy, its market is now predominantly confined to niche indications and developing regions. The trajectory remains subdued, impacted by technological advances, regulatory preferences, and increasing competition from oral and targeted therapies.

Key quantitative metrics, such as marginal decline in sales and the likely stagnation of new approvals, underscore a conservative outlook. However, strategic opportunities exist within biosimilar markets and specific therapeutic niches, provided regulatory and market barriers are effectively navigated.

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Key Takeaways

• Declining Market Share: INTRON A’s sales have significantly diminished due to competition from newer antivirals and immunotherapies.
• Niche Focus: Its current use is mostly limited to specialized indications and regions with limited access to advanced treatments.
• Biosimilar Potential: Patent expirations could introduce biosimilars that may reshape its market landscape but also pose pricing pressures.
• Regulatory Challenges: Safety profiles and administration complexity restrict widespread adoption.
• Future Opportunities: Targeted applications, combination therapies, and biosimilar development could sustain select revenue streams.

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FAQs

1. What are the primary therapeutic uses of INTRON A today?
INTRON A is primarily used for certain cancers (e.g., melanoma, hairy cell leukemia), some viral infections like chronic hepatitis B and C (now less common due to newer antivirals), and rare indications. Its use has declined significantly in hepatitis C due to direct-acting antivirals.

2. How does INTRON A compare to newer biologics in terms of efficacy and safety?
Newer biologics and targeted therapies often demonstrate superior efficacy, improved safety profiles, and easier administration (oral or subcutaneous). INTRON A’s side effect profile, including flu-like symptoms and hematological issues, limits its appeal.

3. What are the prospects for biosimilars of INTRON A?
While biosimilars could reduce costs and expand access, limited regulatory approvals and complex manufacturing have delayed their emergence. The expiration of key patents may eventually facilitate biosimilar development, potentially impacting market dynamics.

4. Are there ongoing combination therapies involving INTRON A?
Research explores combining INTRON A with other agents, particularly in oncology, to enhance immune responses. However, the focus has shifted toward newer immunotherapies, reducing the prominence of interferon in combination regimens.

5. What strategic moves can pharmaceutical companies make regarding INTRON A?
Companies might focus on niche indications, develop biosimilars, or explore new formulations and delivery methods. Collaborations or licensing agreements could optimize manufacturing efficiencies and expand access in emerging markets.

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References:

1. [1] "INTRON A (Interferon alfa-2b) Clinical Pharmacology." FDA Drug Label.
2. [2] "Biologic Market Trends," IQVIA Reports, 2022.
3. [3] "Global Interferon Market Analysis," MarketWatch, 2021.
4. [4] "Biosimilar Development in Biologics," Nature Reviews Drug Discovery, 2020.
5. [5] "Advances in Hepatitis C Treatment," The Journal of Hepatology, 2022.