Interferon alfa-2b - Biologic Drug Details

Summary for interferon alfa-2b

Tradenames:	1
High Confidence Patents:	5
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for interferon alfa-2b
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for interferon alfa-2b

Recent Clinical Trials for interferon alfa-2b

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Boston Children's Hospital	Phase 2
Imperial College London	Phase 2
University of Southampton	Phase 2

See all interferon alfa-2b clinical trials

Recent Litigation for interferon alfa-2b

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Guardant Health, Inc. v. Tempus AI, Inc.	2024-06-11
Natera, Inc. v. NeoGenomics Laboratories, Inc.	2024-01-04
Corteva Agriscience LLC v. Inari Agriculture, Inc.	2023-09-27

See all interferon alfa-2b litigation

PTAB Litigation

Petitioner	Date
Inari Agriculture, Inc.	2024-06-13
Regeneron Pharmaceuticals, Inc.	2019-09-20
Regeneron Pharmaceuticals, Inc.	2019-05-14

See all interferon alfa-2b litigation

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 interferon alfa-2b Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for interferon alfa-2b 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	INTRON A	interferon alfa-2b	For Injection	103132		2002-11-19	Company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2002-07-23	Company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2039-03-29	Company disclosures
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2014-10-11	Company disclosures

3) Low Certainty: US Patents for interferon 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	INTRON A	interferon alfa-2b	For Injection	103132		2039-02-26	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2033-03-11	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2035-12-09	Patent claims search
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2021-05-01	Patent claims search

International Patents for interferon alfa-2b

Country	Patent Number	Estimated Expiration
India	153751
Latvia	5676
Poland	148434
Portugal	73289

Market Dynamics and Financial Trajectory for Interferon Alfa-2b

Introduction to Interferon Alfa-2b

Interferon alfa-2b is a biologic drug derived from human proteins, used to treat a variety of diseases including cancer, viral infections, and other conditions. Its efficacy in treating these diseases has made it a significant player in the pharmaceutical market.

Market Growth and CAGR

The global Interferon Alfa-2b market is projected to witness a high Compound Annual Growth Rate (CAGR) during the forecast period of 2020-2026. This growth is driven by the increasing prevalence of cancer and viral infections globally, as well as the expanding manufacturing sector and foreign investments, particularly in the Asia Pacific region[1][4].

Market Segmentation

By Form

The Interferon Alfa-2b market is segmented into two main forms: powder and liquid. The liquid form is expected to hold the largest market share due to its widespread use in various administration routes such as subcutaneous, intramuscular, intravenous, and intralesional injections[1].

By Route of Administration

Interferon alfa-2b can be administered through several routes, including subcutaneous, intramuscular, intravenous, and intralesional injections. Each route has specific applications and patient groups, contributing to the market's diversity and growth[1].

By Application

The market is segmented into two primary applications: cancer and viral infections. The cancer segment includes treatments for hairy cell leukemia, malignant melanoma, follicular lymphoma, and carcinoid tumor, among others. The viral infection segment includes treatments for chronic hepatitis B and C[1][4].

By Distribution Channel

The distribution channels for Interferon Alfa-2b include retail medical stores, hospitals, and online medical stores. Hospitals dominate the market due to the need for specialized storage conditions and stringent government regulations for the sale of these medicines[1].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is expected to witness considerable growth in the Interferon Alfa-2b market. This region has emerged as a leading producer of Interferon Alfa-2b, driven by expanding manufacturing sectors and increasing foreign investments[1].

North America and Europe

North America and Europe also play significant roles in the market, with established healthcare systems and high demand for biologic treatments. The North American market, for instance, is forecasted to grow significantly from 2023 to 2030[4].

Key Players and Vendor Landscape

The Interferon Alfa-2b market is dominated by several key players, including Schering-Plough, Merck & Co., Biocad, Pharmstandard, Sicor Biotech, Intas, Reliance Life Science, CCL Pharmaceuticals, and others. These companies are involved in various stages of the supply chain, from raw material manufacturing to distribution[1][4].

Cost-Effectiveness and Financial Considerations

Treatment Costs

Interferon alfa-2b is considered an effective but expensive treatment option. For example, in the treatment of basal cell carcinoma, interferon alfa-2b costs between $500 and $760 more per cure than conventional treatments. However, it offers better cosmetic results and can be less expensive in cases requiring extensive home nursing or hospitalization[2].

Cost-Effectiveness Analysis

In high-risk melanoma cases, the projected incremental cost per life-year gained with interferon alfa-2b treatment ranges from $13,700 to $32,600, depending on the follow-up period. This cost must be balanced against the treatment's benefits, which include prolonged relapse-free and total survival[5].

Economic Impact

The overall economic impact of interferon alfa-2b is significant, given its widespread use in treating various diseases. The global biologic market, which includes innovator biologics and biosimilars, was valued at $360 billion in 2019. While innovator products dominate the market, biosimilars are growing rapidly, offering cost-effective alternatives that could influence the financial trajectory of interferon alfa-2b[3].

End-User Landscape

The end-users of Interferon Alfa-2b include major healthcare institutions such as the Mayo Clinic, Cleveland Clinic, and Singapore General Hospital. These institutions play a crucial role in driving the demand for this drug due to their extensive patient bases and advanced treatment capabilities[1].

Challenges and Opportunities

Regulatory Challenges

Stringent government regulations and the need for specialized storage conditions can hamper the market growth of interferon alfa-2b. However, these regulations also ensure the quality and safety of the drug, which is crucial for its efficacy and patient trust[1].

Side Effects and Toxicity

The side effects and toxicity associated with interferon alfa-2b can be significant barriers to its widespread use. Balancing these risks against the treatment's benefits is essential for its continued market growth[5].

Biosimilars

The introduction of biosimilars presents both challenges and opportunities. While biosimilars can offer cost-effective alternatives, they also compete with innovator products, potentially affecting the market share of interferon alfa-2b. However, the growth of biosimilars can also expand the overall biologic market, benefiting all stakeholders[3].

Key Takeaways

• High Growth Potential: The Interferon Alfa-2b market is expected to witness high CAGR due to increasing demand for cancer and viral infection treatments.
• Segmented Market: The market is segmented by form, route of administration, application, and distribution channel, offering diverse growth opportunities.
• Regional Dynamics: Asia Pacific is a key region driving market growth, while North America and Europe also contribute significantly.
• Cost-Effectiveness: Despite being expensive, interferon alfa-2b offers cost-effective solutions in certain treatment scenarios and provides better outcomes.
• Regulatory and Safety Considerations: Stringent regulations and side effects are critical factors that need to be managed to ensure market growth.

FAQs

What are the primary applications of Interferon Alfa-2b?

Interferon alfa-2b is primarily used to treat cancer and viral infections, including hairy cell leukemia, malignant melanoma, follicular lymphoma, carcinoid tumor, chronic hepatitis B, and chronic hepatitis C[1][4].

Which region is expected to drive the growth of the Interferon Alfa-2b market?

The Asia Pacific region is expected to witness considerable growth in the Interferon Alfa-2b market due to its expanding manufacturing sector and increasing foreign investments[1].

What are the main distribution channels for Interferon Alfa-2b?

The main distribution channels include retail medical stores, hospitals, and online medical stores, with hospitals dominating the market due to specialized storage requirements and regulatory norms[1].

How does the cost of Interferon Alfa-2b compare to conventional treatments?

Interferon alfa-2b is generally more expensive than conventional treatments but offers better cosmetic results and can be cost-effective in cases requiring extensive care or hospitalization[2].

What are the key challenges facing the Interferon Alfa-2b market?

The key challenges include stringent regulatory requirements, side effects and toxicity, and competition from biosimilars. However, these challenges also present opportunities for growth and innovation[1][3][5].

Sources

1. Global Interferon Alpha-2b Market Analysis|Size & Forecasts - Global Market Estimates
2. Consideration of the cost of interferon alfa-2b in the treatment of ... - PubMed
3. Realizing Biosimilar Potential in the Middle East & Africa - IQVIA
4. Global Interferon Alfa-2b Market Research Report 2024 - Valuates Reports
5. Economic analysis of adjuvant interferon alfa-2b in high-risk ... - PubMed