PEGINTRON Drug Profile

Summary for Tradename: PEGINTRON

High Confidence Patents:	16
Applicants:	2
BLAs:	2
Recent Clinical Trials:	See clinical trials for PEGINTRON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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. General 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 PEGINTRON Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PEGINTRON Derived from 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	5,395,760	2010-05-10	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,605,690	2015-02-08	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,618,698	2015-06-06	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,908,621	2017-04-29	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,945,397	2016-05-16	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

International Patents for PEGINTRON

Country	Patent Number	Estimated Expiration
Japan	2005015464
Denmark	1039922
Monaco	1396
Japan	H03259098
China	1062907

Supplementary Protection Certificates for PEGINTRON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300008	Netherlands		PRODUCT: ETANERCEPTUM
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (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

Market Dynamics and Financial Trajectory for the Biologic Drug: PEGINTRON

Last updated: July 8, 2025

Introduction to PEGINTRON

PEGINTRON, a pegylated interferon alpha-2b developed by Merck (formerly Schering-Plough), has played a pivotal role in treating chronic hepatitis C since its approval by the FDA in 2001. As a biologic drug, it combines interferon with polyethylene glycol to enhance its efficacy and prolong its half-life, making it a cornerstone therapy before the advent of direct-acting antivirals. This article examines the current market dynamics and financial trajectory of PEGINTRON, offering business professionals actionable insights into its evolving landscape amid competition, patent challenges, and shifting healthcare demands.

Overview of PEGINTRON's Market Dynamics

The global hepatitis C market, valued at approximately $20 billion in 2023, reflects a dynamic interplay of innovation, regulatory shifts, and patient access issues. PEGINTRON occupies a niche within this space, primarily as a second-line or combination therapy, but its market position has weakened due to the rise of more effective oral treatments.

Competition from newer drugs like Gilead Sciences' Harvoni and AbbVie's Mavyret has eroded PEGINTRON's share. These direct-acting antivirals offer cure rates above 95% with shorter treatment durations, compared to PEGINTRON's regimen of weekly injections and lower efficacy rates of 40-50%. In the U.S., PEGINTRON's prescriptions dropped by 60% between 2014 and 2020, according to IMS Health data, as physicians shifted to these alternatives.

Regulatory factors further shape PEGINTRON's dynamics. The FDA's approval of biosimilars, such as those from Roche and Biocon, intensifies pressure. In Europe, the European Medicines Agency granted marketing authorization for a PEGINTRON biosimilar in 2019, leading to price erosion. Pricing strategies remain a key lever; Merck prices PEGINTRON at around $1,000 per week in the U.S., but negotiations with payers and government programs have reduced net revenues by up to 30% in recent years.

Emerging markets in Asia-Pacific and Latin America present growth opportunities. In China, where hepatitis C prevalence exceeds 1%, PEGINTRON sales surged 25% year-over-year in 2022, driven by expanded access through national health initiatives. However, supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily halted distributions in 2021, highlighting vulnerabilities in global logistics.

Financial Performance of PEGINTRON

Merck's financial reports reveal PEGINTRON's trajectory as a tale of peak earnings followed by decline. In 2005, at the height of its popularity, PEGINTRON generated over $2 billion in annual global sales, contributing significantly to Merck's oncology and antiviral portfolio. By 2023, revenues had plummeted to approximately $300 million, a 85% drop from its peak, as reflected in Merck's Q4 earnings statements.

This downturn stems from patent expirations. PEGINTRON's core patents expired in the U.S. in 2016 and in Europe by 2019, opening the door to generics and biosimilars. Merck's 10-K filings indicate that generic competition reduced PEGINTRON's U.S. market exclusivity, slashing prices by 40-50%. Consequently, gross margins on PEGINTRON fell from 75% in 2010 to 50% in 2023, pressured by manufacturing costs and rebates.

Despite these challenges, Merck has optimized financial returns through strategic partnerships. In 2022, a licensing deal with a generic manufacturer in India expanded PEGINTRON's reach in developing regions, generating an additional $50 million in licensing fees. Financial projections from Evaluate Pharma estimate PEGINTRON's global sales to stabilize at $250-300 million annually through 2025, with modest growth in non-Western markets offsetting declines elsewhere.

Investment in R&D has been minimal for PEGINTRON, as Merck pivots to next-generation therapies. The company's 2023 annual report allocates less than 5% of its antiviral budget to PEGINTRON maintenance, redirecting funds toward innovative drugs like Keytruda. This shift underscores PEGINTRON's transition from a revenue driver to a legacy asset, with return on investment metrics showing a compound annual growth rate of -15% over the past decade.

Future Trajectory and Challenges

Looking ahead, PEGINTRON's trajectory hinges on biosimilar threats and market adaptation. By 2026, analysts from IQVIA predict that biosimilars could capture 70% of PEGINTRON's remaining market, potentially halving its revenues. Merck's response includes cost-cutting measures, such as streamlining production facilities, which reduced operational expenses by 20% in 2023.

Opportunities lie in niche applications. Recent studies, published in the Journal of Hepatology, suggest PEGINTRON's potential in treating certain hepatitis C genotypes resistant to oral antivirals, potentially extending its lifespan. In Africa, where hepatitis C rates are rising, Merck's expanded access programs could drive a 15% sales uptick by 2025.

However, geopolitical and economic factors pose risks. Currency fluctuations in emerging markets have eroded Merck's profits by 10% in 2023, while stringent regulations on biologics in the EU may delay biosimilar approvals. Business professionals should monitor these elements, as they could influence investment decisions in Merck's portfolio.

Conclusion

In summary, PEGINTRON's market dynamics and financial trajectory illustrate the volatile nature of biologic drugs in a rapidly evolving healthcare landscape. While competition and patent losses have diminished its prominence, strategic adaptations in pricing and market expansion offer pathways for sustained, albeit modest, returns.

Key Takeaways

• PEGINTRON's market share has declined sharply due to superior competitors, with U.S. prescriptions dropping 60% since 2014.
• Patent expirations have led to an 85% revenue fall from its 2005 peak, now stabilizing at around $300 million annually.
• Emerging markets in Asia-Pacific provide growth potential, potentially offsetting declines in mature regions.
• Biosimilar threats could further erode revenues by 2026, emphasizing the need for Merck to innovate or pivot.
• Investors should weigh niche opportunities, such as resistant hepatitis C treatments, against ongoing pricing pressures.

Frequently Asked Questions

1. What factors have most impacted PEGINTRON's market dynamics?
The rise of direct-acting antivirals like Harvoni has significantly reduced demand for PEGINTRON, alongside patent expirations that enabled biosimilar competition.

2. How has PEGINTRON's financial performance evolved recently?
PEGINTRON's revenues have dropped from over $2 billion in 2005 to about $300 million in 2023, driven by generics and pricing pressures, but licensing deals have provided some stability.

3. What opportunities exist for PEGINTRON in emerging markets?
In regions like China and India, increasing hepatitis C prevalence and access programs could boost PEGINTRON sales by 15-25% in the next few years.

4. How do biosimilars affect PEGINTRON's future trajectory?
Biosimilars are expected to capture up to 70% of PEGINTRON's market by 2026, potentially halving revenues and forcing Merck to adapt its strategies.

5. What should investors monitor for PEGINTRON-related decisions?
Key areas include regulatory developments, currency impacts in global markets, and Merck's R&D shifts toward newer therapies.

Sources

1. Merck. 2023 Annual Report and 10-K Filing. Available at: Merck Investor Relations.
2. IQVIA Institute. 2023 Report on Global Medicine Spending and Usage. Available at: IQVIA Publications.
3. Evaluate Pharma. 2023 World Preview: Outlook to 2028. Available at: Evaluate Pharma Database.
4. Journal of Hepatology. 2022 Study on Hepatitis C Treatment Efficacy. Available at: Elsevier Publications.