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
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. 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	2012-03-07	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,605,690	2014-02-25	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,618,698	2003-12-13	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,908,621	2015-11-02	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,945,397	2009-09-11	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,951,974	2013-11-10	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	2031-04-05	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,577,154	2029-05-13	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	2033-12-23	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,656,152	2029-01-29	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,844,066	2037-03-01	Patent claims search

International Patents for PEGINTRON

Country	Patent Number	Estimated Expiration
Australia	7246281
Canada	2123593
Singapore	71179
Australia	630497
Czech Republic	281542
Argentina	017435

Supplementary Protection Certificates for PEGINTRON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 15/2000	Austria		PRODUCT NAME: ETANERCEPT
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203
C300008	Netherlands		PRODUCT: ETANERCEPTUM
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
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201

PEGINTRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEGINTRON

Introduction to PEGINTRON

PEGINTRON, a PEGylated form of interferon alfa-2b, is a biologic drug used primarily in the treatment of chronic hepatitis B and C, as well as some types of cancer and multiple sclerosis. Understanding the market dynamics and financial trajectory of PEGINTRON involves analyzing several key factors, including market size, growth rate, end-user segments, and recent developments.

Market Size and Growth Rate

The global PEGylation proteins market, which includes PEGINTRON, is experiencing significant growth. As of 2023, the global PEGylation proteins market was valued at approximately $1.93 billion and is projected to reach around $5.59 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 11.2% from 2024 to 2033[1].

End-User Segments

The demand for PEGINTRON is driven by various end-user segments, with pharmaceutical and biotechnology companies being the largest contributors. In 2023, these companies accounted for a revenue share of 42% in the PEGylation proteins market[1].

Application in Cancer and Hepatitis

PEGINTRON is particularly significant in the treatment of cancer and hepatitis. The cancer application segment within the PEGylation proteins market is expected to grow at a CAGR of 13.5% from 2024 to 2033, driven by the increasing prevalence of cancer and the need for effective treatments[1].

Regional Market Share

North America holds a substantial market share in the PEGylation proteins market, including PEGINTRON. In 2023, North America accounted for around 35.14% of the global market share[1].

Key Players and Recent Developments

Several key players are involved in the development and distribution of PEGINTRON and other PEGylated proteins.

Merck KGaA

Merck KGaA, one of the major players in the PEGylation proteins market, has been actively involved in expanding its capabilities. For instance, in February 2022, Merck completed the acquisition of Exelead and announced plans to invest more than €500 million in technology scale-up[1].

Nektar Therapeutics

Nektar Therapeutics, another significant player, presented preclinical data from its novel PEGylated interferon gamma program, NKTR-288, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022. This highlights the ongoing innovation and research in PEGylated proteins[1].

Financial Performance and Projections

The financial performance of PEGINTRON is closely tied to the overall growth of the PEGylation proteins market.

Revenue Projections

The U.S. PEGylation proteins market, which includes PEGINTRON, is expected to reach around $1.46 billion by 2033, growing at a CAGR of 11.9% from 2024 to 2033. This growth is driven by increasing demand for biologic treatments and advancements in PEGylation technology[1].

Cost and Pricing

The cost-effectiveness of PEGINTRON and other PEGylated proteins is a critical factor in their adoption. The process of PEGylation, which modifies the physical and chemical properties of biomedical molecules, enhances the pharmacokinetic behavior of drugs, potentially reducing the need for frequent dosing and improving patient compliance[1].

Competitive Landscape

The market for PEGINTRON is competitive, with several major players vying for market share.

Major Competitors

Companies such as Thermo Fisher Scientific, Inc., Abcam plc, Enzon Pharmaceuticals, Inc., Merck KGaA, and Celares GmbH are key competitors in the PEGylation proteins market. These companies are investing heavily in research and development to improve PEGylation technologies and expand their product portfolios[1].

Regulatory and Technological Advancements

Regulatory approvals and technological advancements play a crucial role in the market dynamics of PEGINTRON.

Expedited Approval Pathways

The use of PEGylation technology can benefit from established clinical safety and efficacy data, which may allow for expedited approval pathways provided by regulatory authorities such as the FDA. This can reduce drug development risk and accelerate the market entry of new PEGylated products[4].

Clinical Trials and Research

Ongoing clinical trials and research in PEGylated proteins, including PEGINTRON, are driving innovation and enhancing therapeutic efficacy. For example, Nektar Therapeutics' preclinical data on NKTR-288 highlights the potential for new PEGylated interferon gamma treatments[1].

Market Challenges and Opportunities

Despite the growth potential, the market for PEGINTRON faces several challenges and opportunities.

Increasing Demand for Biologics

The increasing demand for biologic treatments, particularly in the areas of cancer and hepatitis, presents a significant opportunity for PEGINTRON. The high target affinity and specificity of interferons, such as PEGINTRON, are key drivers of this demand[5].

High Development Costs

The development of PEGylated proteins is costly and involves complex processes. However, advancements in technology and the potential for expedited regulatory approvals can mitigate some of these costs[4].

Key Takeaways

• Market Growth: The global PEGylation proteins market, including PEGINTRON, is expected to grow significantly, reaching $5.59 billion by 2033.
• End-User Segments: Pharmaceutical and biotechnology companies are the largest end-users, accounting for 42% of the market share in 2023.
• Regional Dominance: North America holds a substantial market share, with 35.14% in 2023.
• Key Players: Companies like Merck KGaA and Nektar Therapeutics are driving innovation and expansion in the market.
• Financial Projections: The U.S. market for PEGylation proteins is projected to reach $1.46 billion by 2033, growing at a CAGR of 11.9%.
• Regulatory and Technological Advancements: Expedited approval pathways and ongoing clinical trials are crucial for market growth.

FAQs

What is the expected global market size for PEGylation proteins by 2033?

The global PEGylation proteins market is expected to reach around $5.59 billion by 2033[1].

Which region holds the largest market share in the PEGylation proteins market?

North America holds the largest market share, accounting for around 35.14% in 2023[1].

What is the CAGR for the U.S. PEGylation proteins market from 2024 to 2033?

The U.S. PEGylation proteins market is expected to grow at a CAGR of 11.9% from 2024 to 2033[1].

Which companies are key players in the PEGylation proteins market?

Key players include Thermo Fisher Scientific, Inc., Abcam plc, Enzon Pharmaceuticals, Inc., Merck KGaA, and Celares GmbH[1].

What are the primary applications of PEGINTRON?

PEGINTRON is primarily used in the treatment of chronic hepatitis B and C, as well as some types of cancer and multiple sclerosis[5].

Sources

1. Biospace: PEGylation Proteins Market Size to Worth Around US$ 5.59 Billion by 2033
2. Investopedia: Price/Earnings-to-Growth (PEG) Ratio: What It Is and the Formula
3. Merck: Merck Announces Fourth Quarter and Full Year 2010 Financial Results
4. Ascendis Pharma: Ascendis Pharma A/S
5. Mordor Intelligence: Interferons Market Analysis | Industry Forecast, Size & Report