PEGINTRON Drug Profile

Summary for Tradename: PEGINTRON

High Confidence Patents:	36
Applicants:	2
BLAs:	2
Recent Clinical Trials:	See clinical trials for PEGINTRON

Recent Clinical Trials for PEGINTRON

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Rockefeller University	Phase 1
Luis Montaner	Phase 1
Philadelphia Fight	Phase 1

See all PEGINTRON 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 PEGINTRON Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PEGINTRON 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
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2037-03-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for PEGINTRON 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
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949		2037-03-01	Patent claims search

International Patents for PEGINTRON

Country	Patent Number	Estimated Expiration
Argentina	242833
Denmark	365185
Mexico	9203660
Spain	2513866
Australia	7600496
Poland	2600930

Supplementary Protection Certificates for PEGINTRON

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
SZ 15/2000	Austria		PRODUCT NAME: ETANERCEPT

Market Dynamics and Financial Trajectory for PEGINTRON

Last updated: September 22, 2025

Introduction

PEGINTRON (peginterferon alfa-2b) remains a key player in the biologic therapeutic landscape, notably for hepatitis B and C, as well as certain oncology applications. Its evolving market encompasses regulatory changes, competitive innovations, and shifting healthcare paradigms, influencing its commercial viability. This analysis evaluates the current market dynamics and forecasts the financial trajectory of PEGINTRON, offering insights critical for investors, pharmaceutical strategists, and healthcare professionals.

Historical Context and Regulatory Milestones

PEGINTRON was approved by the U.S. Food and Drug Administration (FDA) in 2001 for chronic hepatitis B and C. Its pegylation process enhances pharmacokinetics, resulting in less frequent dosing compared to conventional interferons. Despite its pioneering role, later years witness increased competition from direct-acting antivirals (DAAs) and novel biologics, leading to declining prescriptions and revenue.

Regulatory landscapes also influence its trajectory. In 2017, the FDA updated dosing guidelines and added safety warnings concerning neuropsychiatric and hematologic adverse effects, which may impact prescriber confidence for certain patient populations. The European Medicines Agency (EMA) has issued similar guidance, affecting market access internationally.

Market Dynamics

Competitive Environment

The antiviral market has transformed significantly with the advent of oral DAAs such as sofosbuvir and ledipasvir. These agents offer higher cure rates, shorter regimens, and improved tolerability, effectively supplanting interferon-based therapies. As a result, PEGINTRON’s market share has contracted substantially, primarily limited to cases where DAAs are contraindicated or have failed.

In oncology, PEGINTRON's indications are more narrow, with a basket of conditions like melanoma and certain hematologic disorders. However, newer immunotherapies and targeted agents present competing options, challenging PEGINTRON's relevance.

Market Penetration and Prescriber Trends

While PEGINTRON's dominant period has waned, it maintains niche usage, notably in regions with limited access to newer therapies or in specific patient subsets. Prescriber familiarity and existing manufacturing infrastructure support continued, albeit diminished, demand.

Global strategies also impact its trajectory. Countries with robust healthcare systems and formulary constraints favor more cost-effective, highly efficacious DAAs and biologics. Conversely, certain emerging markets continue to rely on older interferon therapies due to cost considerations, permitting some market resilience for PEGINTRON.

Pricing and Reimbursement Dynamics

Pricing pressures persist, intensified by biosimilar developments and competition from orally administered agents. Reimbursement policies increasingly favor treatments with superior efficacy and tolerability, leading to formulary exclusions for PEGINTRON in some jurisdictions.

However, its lower cost compared to newer biologics preserves a competitive niche, especially in resource-limited settings. Patent statuses and exclusivity periods influence pricing strategies, with recent patent expirations easing generic competition in specific regions.

Financial Trajectory Forecast

Historical Revenue Trends

From a peak in the early 2000s, PEGINTRON’s revenues have experienced a steady decline, reflecting broader shifts within the hepatitis C landscape. In 2015, global sales exceeded $600 million; by 2022, estimates suggest revenues falling below $200 million, driven by reduced prescriber usage and market saturation.

Forecasting Future Revenues

Projections indicate a continued decline in PEGINTRON’s financial performance over the next five years, barring new indications or formulation improvements. Key factors shaping this outlook include:

• Market Saturation: The majority of eligible hepatitis C patients have transitioned to DAAs, limiting PEGINTRON’s applicability.
• Regulatory Limitations: Evolving safety concerns may restrict its use, especially in vulnerable populations.
• Emerging Indications: Potential expansions into oncological or rare disease niches could bolster revenues; ongoing clinical trials are pivotal.
• Cost and Price Competition: Biosimilars and cheaper generics decrease net pricing, compress margins.

Assuming an annual decline rate of approximately 10-15%, revenues could diminish to below $100 million by 2028. However, targeted development efforts for niche indications or biosimilar collaborations could stabilize or slightly augment revenues in select markets.

Developmental and Strategic Outlook

Investments in biosimilar versions could offset patent expirations, providing a new revenue stream. Alternatively, repositioning PEGINTRON in combination regimens or for indications like certain hematologic cancers may rejuvenate its market prospects.

Strategic Implications

• Niche Focus: Companies may concentrate on underserved populations or regions where newer therapies are unavailable.
• Pricing Strategy: Maintaining a cost advantage in emerging markets remains critical.
• Innovative Formulations: Extended dosing intervals or reduced side-effect profiles could enhance prescribing appeal.
• Pipeline Expansion: Participation in combination therapies or novel indications is essential for long-term viability.

Key Drivers and Challenges

Driver	Impact	Challenge
Emergence of DAAs	Erode hepatitis C market share	Limited efficacy in contraindicated cases
Patent Expirations	Biosimilar competition	Price erosion pressures
Safety Profile	Regulatory and prescriber acceptance	Managing adverse effects
Regional Variations	Differential adoption	Access and reimbursement barriers

Conclusion

PEGINTRON’s market dynamics showcase a classic shift from injectable biologics towards oral, highly efficacious therapies. While its relevance has declined globally, niche markets and emerging indications sustain modest revenue streams. The future financial trajectory hinges on strategic initiatives, regulatory developments, and evolving treatment landscapes. Firms leveraging biosimilars, repositioning in oncology, or developing combination regimens could extend its commercial lifespan, but broad market decline appears inevitable absent significant innovation.

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Key Takeaways

• PEGINTRON’s core market has contracted, driven by the advent of DAAs and newer biologics.
• Regulatory updates and safety concerns influence prescriber confidence and market access.
• Revenues are forecasted to decline steadily, with potential stabilization only through niche indications or biosimilar expansion.
• Strategic maneuvers, including pipeline diversification and regional focus, are critical to maintaining viability.
• The drug exemplifies the broader trend of biologic evolution, underscoring the importance of innovation in sustaining market relevance.

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FAQs

1. What are the primary indications for PEGINTRON today?
PEGINTRON is mainly used in limited cases of hepatitis B management and select oncologic conditions, but its use has significantly declined due to competition from DAAs and newer biologics.

2. How does the emergence of oral DAAs affect PEGINTRON’s market potential?
Oral DAAs have replaced interferon-based therapies for hepatitis C, leading to a sharp decline in PEGINTRON prescriptions and revenues, reserving its use for contraindication cases.

3. Are biosimilars a threat to PEGINTRON’s revenues?
Yes; patent expirations and biosimilar developments threaten to further reduce pricing power and market share, especially in regions with cost-conscious healthcare systems.

4. Can PEGINTRON find renewed success in other therapeutic areas?
Potentially, through clinical trials targeting oncology or rare diseases, but this requires significant investment and regulatory approval.

5. What strategic steps should manufacturers pursue to extend PEGINTRON’s commercial viability?
Investing in biosimilar development, exploring new indications, improving formulations, and leveraging regional markets where older therapies are still favored can help sustain revenues.

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Sources:

1. FDA Approval Documents for PEGINTRON (2001).
2. Market analysis reports from GlobalData.
3. Treatment guidelines from American Association for the Study of Liver Diseases (AASLD).
4. Recent patent and biosimilar patent filings (European Patent Office).