Peginterferon alfa-2b - Biologic Drug Details

Summary for peginterferon alfa-2b

Tradenames:	2
High Confidence Patents:	16
Applicants:	2
BLAs:	2
Recent Clinical Trials:	See clinical trials for peginterferon alfa-2b

Recent Clinical Trials for peginterferon alfa-2b

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Xiamen Humanity Hospital	NA
Xiamen Hospital of Traditional Chinese Medicine	NA
Children's Hospital of Soochow University	NA

See all peginterferon alfa-2b 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 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 peginterferon alfa-2b Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for peginterferon alfa-2b 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	PEGINTRON	peginterferon alfa-2b	Injection	103949		2032-03-29	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2038-12-19	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2038-05-03	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2037-12-21	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2037-11-08	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for peginterferon alfa-2b 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	PEGINTRON	peginterferon alfa-2b	Injection	103949		2032-03-29	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2038-12-19	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2038-05-03	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2037-12-21	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2037-11-08	Patent claims search

International Patents for peginterferon alfa-2b

Country	Patent Number	Estimated Expiration
Finland	82713
Latvia	10506
Spain	2513866
Singapore	71179
Poland	2600930

Supplementary Protection Certificates for peginterferon alfa-2b

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00C0015	France		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: IKS- N 55365 20000201
15/2000	Austria		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
132000900852970	Italy
0090011-8, 0091011-7	Sweden		NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201

Market Dynamics and Financial Trajectory for the Biologic Drug: Peginterferon Alfa-2b

Last updated: July 30, 2025

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Introduction

Peginterferon alfa-2b, a polyethylene glycol-conjugated interferon-alpha-2b, is a biologic agent primarily employed in treating chronic hepatitis C virus (HCV) infections, certain types of melanoma, and other hematologic malignancies. Since its commercial introduction, it has played a significant role within antiviral and oncologic therapeutic landscapes, driven by pathogenic understanding and evolving treatment protocols. This analysis explores the market dynamics influencing peginterferon alfa-2b and forecasts its financial trajectory amid shifting healthcare paradigms.

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Historical Context and Therapeutic Role

Peginterferon alfa-2b received regulatory approval in 2001, marketed under brands such as PEG-Intron (Merck) and others. Its mechanism involves immune modulation, enhancing antiviral activity and antitumor responses. Historically, it was a cornerstone in combination therapies for chronic HCV, notably alongside ribavirin, before the advent of direct-acting antivirals (DAAs). Its use in melanoma, particularly as adjuvant therapy, was validated following promising clinical trial results.

However, with the rapid expansion of DAAs—such as sofosbuvir, ledipasvir, and velpatasvir—public health strategies pivoted toward regimens with higher cure rates, shorter durations, and fewer adverse effects. Consequently, the demand for peginterferon alfa-2b experienced significant decline.

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Current Market Landscape

Market Size and Segmentation

The global biologics market is projected to reach USD 495 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 11% [1]. Peginterferon alfa-2b, initially a blockbuster, has diminished in its outpatient antiviral application but retains niche positions in specific indications such as:

• Hepatitis C: Now largely supplanted by DAAs.
• Melanoma and Oncologic Applications: Limited, driven by recent clinical advancements.
• Rare Autoimmune Disorders: Emerging off-label or experimental uses.

The current market contribution of peginterferon alpha-2b is predominantly through off-patent or generic formulations, with a residual, declining annual revenue estimated in the low tens of millions USD globally.

Competitive Forces

The competitive landscape has been redefined by:

• Direct-Acting Antivirals (DAAs): These have rendered peginterferon-based regimens obsolete for most HCV patients, offering cure rates >95%, shorter therapy durations, and better tolerability.
• Biologic Innovation: The advent of newer immunotherapies, checkpoint inhibitors, and personalized medicine tools diminishes the relevance of traditional interferons.
• Off-Patent & Generic Markets: Several manufacturers produce peginterferon alfa-2b generics, which sustain low-level demand for specific niches.

Regulatory and Reimbursement Trends

Global health agencies and payers increasingly prioritize therapies with robust evidence of efficacy and cost-effectiveness. DAAs benefit from reimbursement schemes favoring shorter, more effective treatments. Regulatory agencies may restrict newer approvals to specific, unmet needs where peginterferon remains relevant, such as in pediatric or autoimmune contexts.

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Market Dynamics Influencing Future Trajectory

1. Obsolescence vs. Niche Applications

The dominant trend toward DAAs and targeted immunotherapies forecasts a continued decline in peginterferon alfa-2b's market share for HCV. Its residual market persists only within niche or refractory indications. However, its role in certain autoimmune or viral-related indications might be revisited through clinical research, possibly revitalizing its market.

2. Technological Innovations and Therapeutic Paradigm Shifts

Biotechnology advancements aim to develop interferon variants with improved efficacy, reduced side effects, or alternative delivery methods. These innovations could either replace peginterferon alfa-2b or integrate into combination therapies, gradually supplanting existing formulations.

3. Geographic and Demographic Factors

In emerging markets with limited access to DAAs, peginterferon alfa-2b remains relevant. Prices and regulatory hurdles influence its adoption, especially in resource-constrained settings. Conversely, in developed markets, minimal demand and evolving treatment standards curb its growth.

4. Patent and Regulatory Environment

Most formulations of peginterferon alfa-2b are now off-patent, fostering generic competition and reducing prices. This environment limits potential profit margins for innovator companies but sustains sovereign or institutional procurement for specific uses.

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Financial Projection and Outlook

Given current market trends, the revenue trajectory for peginterferon alfa-2b indicates continued decline:

• Short-term (1–3 years): Marginal stabilization in niche indications, but overall revenue falling by approximately 10–15% annually.
• Mid to Long-term (3–10 years): Anticipated near-complete obsolescence in hepatitis C treatment contexts; residual use confined to limited autoimmune therapies or off-label indications.

Manufacturers may experience further margin erosion due to generic competition, price pressures, and decreasing demand. Investment in repurposing or developing next-generation interferons would be necessary to alter this trajectory.

Strategic Implications for Stakeholders

• Pharmaceutical Developers: Focus on novel biologics overshadowing traditional interferons.
• Investors: Prioritize companies with diversified portfolios beyond peginterferon alfa-2b.
• Healthcare Providers and Payers: Shift toward cost-effective DAAs and targeted immunotherapies, minimizing support for outdated biologics.

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Key Takeaways

• Market decline driven by innovation: The surge of DAAs for HCV and advanced immunotherapies limits peginterferon alfa-2b’s relevance.
• Niche persistence: Some limited use remains in resource-limited settings or specific autoimmune conditions.
• Generic competition: Off-patent formulations reduce profitability and market control.
• Future prospects: Likely minimal, barring breakthroughs in interferon engineering or new therapeutic indications.
• Investment considerations: Stakeholders should monitor emerging therapies and regulatory shifts that may further diminish peginterferon alfa-2b's market relevance.

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FAQs

1. Is peginterferon alfa-2b still reimbursed in major markets?
Yes, in certain countries, especially where generic formulations are available and off-label uses are pursued, reimbursement persists. However, coverage is shrinking as newer therapies dominate.

2. Are there any new indications for peginterferon alfa-2b?
Current research explores its role in certain rare autoimmune disorders, though clinical validation is limited. Its primary use remains outdated in hepatitis C treatment.

3. How does the cost of peginterferon alfa-2b compare with newer biologics?
Generic peginterferon alfa-2b costs significantly less than newer, patent-protected biologic therapies; however, its reduced efficacy and tolerability diminish its attractiveness.

4. Can peginterferon alfa-2b be integrated into combination therapies?
Potentially, but ongoing developments favor agents with better safety profiles and efficacy, reducing interest in interferon-based combinations.

5. What are the prospects for peginterferon alfa-2b in global health?
In low-resource settings, it remains relevant due to affordability, but toxicity and efficacy concerns limit its use in favor of more modern, accessible therapies.

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References

1. Grand View Research. Biologics Market Size & Share Report, 2021–2028.