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
Luis Montaner	Phase 1
Philadelphia Fight	Phase 1
University of Pennsylvania	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	10,383,876	2032-03-29	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,577,154	2038-12-19	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,596,173	2038-05-03	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,626,100	2037-12-21	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,656,152	2037-11-08	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,844,066	2037-03-01	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,395,760	2010-05-10	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	10,383,876	2032-03-29	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,577,154	2038-12-19	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,596,173	2038-05-03	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,626,100	2037-12-21	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,656,152	2037-11-08	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,844,066	2037-03-01	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,933,061	2038-12-21	Patent claims search

International Patents for PEGINTRON

Country	Patent Number	Estimated Expiration
Denmark	2251453
Israel	254215
Japan	6263217
Serbia	53811
Hungary	E064909
Japan	2015164936
Singapore	92891

Supplementary Protection Certificates for PEGINTRON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300008	Netherlands		PRODUCT: ETANERCEPTUM
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203
132000900852970	Italy
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
0090011-8, 0091011-7	Sweden		NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201

Market Dynamics and Financial Trajectory for PEGINTRON

Last updated: April 10, 2026

What is the current market position of PEGINTRON?

PEGINTRON (peginterferon alfa-2b) is a biologic used primarily to treat hepatitis C virus (HCV) infection and certain types of melanoma. It is marketed by Merck & Co., with U.S. approval dating back to 2001. The drug's market was historically robust but has declined significantly due to the advent of direct-acting antivirals (DAAs).

How has the hepatitis C treatment landscape evolved?

The hepatitis C market shifted from interferon-based therapies to DAAs, such as Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofobusvir/velpatasvir). These newer treatments achieve cure rates above 95% with fewer side effects and shorter treatment durations. Interferon-based therapies like PEGINTRON now represent a declining share of the market.

• Pre-2015: PEGINTRON was a primary therapy, with peak sales approaching $1.2 billion (2014).
• Post-2015: Rapid decline as DAAs gained approval, with PEGINTRON sales falling below $100 million globally by 2020, primarily in niche indications.

What are the existing market challenges for PEGINTRON?

Multiple factors diminish PEGINTRON’s market potential:

• Efficacy: Lower cure rates compared to DAAs.
• Side Effect Profile: Significant adverse effects including flu-like symptoms, depression, and cytopenias.
• Treatment Duration: Longer courses relative to DAAs.
• Regulatory Environment: Many regulators have prioritized DAA approval over interferon-based regimens.
• Market Competition: Presence of numerous highly effective, well-tolerated oral regimens.

What is the current and projected revenue outlook?

Given the decline in hepatitis C indications, PEGINTRON’s revenue has stabilized at a low level. For 2022, global sales are estimated at around $50 million, primarily from Italy and some emerging markets where DAAs remain less accessible or approved.

Future projections:

Year	Estimated Global Sales	Notes
2023	$45–55 million	Slight recovery in certain markets, but overall stable/evolving downward trend.
2025	<$40 million	Continued decline expected as DAA accessibility improves worldwide.

Secondary indications, such as certain melanoma treatments, are limited and do not significantly alter the revenue outlook.

How do patent protections and generic entry influence market trajectory?

PEGINTRON's original patents expired in several key markets between 2015 and 2017. No recent patent extensions exist, facilitating generic competition that further depresses prices and sales. Price erosion is ongoing, with generic versions priced up to 70% lower than branded PEGINTRON.

What are potential strategic moves for stakeholders?

• Manufacturers: Focus shifts towards niche uses such as rare indications or post-transplant hepatitis C.
• Investors: Should consider the diminishing revenue trend, with limited growth prospects unless a novel formulation or indication emerges.
• Regulators: No major regulatory approvals are anticipated given the shift towards DAAs, unless new data on expanded uses or improved formulations surface.

What alternative market opportunities exist?

PEGINTRON may see limited use in combination with other agents for resistant hepatitis C strains or in regions with limited access to DAAs. However, these are unlikely to reverse overall decline trends.

Summary

• PEGINTRON has transitioned from a frontline hepatitis C treatment to a niche, low-revenue product.
• The hepatitis C market’s shift to DAAs has pushed PEGINTRON’s sales downward since 2015.
• Sales are projected to remain stable at best, with a further decline forecasted due to increased generic competition and minimal clinical relevance in new indications.
• Patent expirations and price reductions accelerate the decline process.
• Strategic focus should shift away from PEGINTRON unless new indications or formulations significantly alter its market dynamics.

Key Takeaways

• PEGINTRON’s initial success was driven by interferon-based hepatitis C therapies.
• The advent of DAAs has rendered PEGINTRON largely obsolete in primary treatment settings.
• Revenue decline aligns with patent expirations and market evolution toward oral regimens.
• The drug remains applicable in limited niche contexts, but no growth trajectory exists.
• Stakeholders should monitor the continued erosion of market share and consider potential for repurposing or discontinuation.

FAQs

1. How long will PEGINTRON remain on the market?
While no official phase-out, sales are expected to decline to minimal levels by 2025, with regulatory and manufacturing support possibly phased out within the next decade.

2. Are there any emerging indications that could revive PEGINTRON’s market?
Current evidence does not suggest significant new indications. Its role is confined to niche groups and specific cases.

3. How do pricing strategies impact the drug’s revenue?
Generic competition and price erosion have reduced revenue by over 70% since patent expirations, emphasizing volume over price in remaining markets.

4. What is the primary driver for the decline in PEGINTRON sales?
The availability of superior oral DAA treatments with higher efficacy and better tolerability.

5. Could combination therapies involving PEGINTRON gain new approval?
Unlikely, given the dominance of DAAs and limited benefit of interferon-based therapies, but research on resistant strains or specific populations may prolong some use.

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References

[1] U.S. Food and Drug Administration. (2001). PEGINTRON (peginterferon alfa-2b) prescribing information.

[2] IQVIA. (2022). Global hepatitis C treatment market analysis.

[3] EvaluatePharma. (2022). Sales data and patent expiry timelines for PEGINTRON and competitors.

[4] World Health Organization. (2021). Global hepatitis report.