INTRON A Drug Profile

Summary for Tradename: INTRON A

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for INTRON A
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTRON A

Recent Clinical Trials for INTRON A

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
RWTH Aachen University	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2
Roswell Park Cancer Institute	Phase 1/Phase 2

See all INTRON A clinical trials

Recent Litigation for INTRON A

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 INTRON A 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 INTRON A 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 INTRON A Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for INTRON A 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
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2020-08-26	Company disclosures

3) Low Certainty: US Patents for INTRON A 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
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		2036-01-08	Patent claims search

International Patents for INTRON A

Country	Patent Number	Estimated Expiration
Portugal	72322
South Africa	814375
Denmark	158771
South Korea	970706017
Australia	3727995

INTRON A Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: INTRON A

Overview of INTRON A

INTRON A, an interferon alfa-2b, is a biologic drug used in the treatment of various conditions, including hepatitis B and C, hairy cell leukemia, and certain types of cancer. To understand its market dynamics and financial trajectory, we need to delve into several key areas.

Global Interferons Market Context

The global interferons market, which includes INTRON A, is projected to grow significantly over the coming years. As of 2022, the market was valued at approximately USD 9.4 billion and is expected to reach USD 13.8 billion by 2032, growing at a CAGR of 3.9% during this period[1].

Market Drivers

Several factors are driving the growth of the interferons market, including:

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as multiple sclerosis, hepatitis, and certain cancers is a significant driver. For instance, multiple sclerosis affects an estimated 2.5 million people worldwide, with the number of women diagnosed increasing annually[1].

Novel Drug Delivery and Combination Therapies

Advancements in drug delivery systems and the development of combination therapies are enhancing the efficacy and patient compliance of interferons like INTRON A. This includes novel routes of administration, such as intramuscular injections, which have been approved for other interferon products[1].

Biosimilar Competition

The advent of biosimilars is expected to impact the market dynamics. While biosimilars can reduce prices and increase accessibility, they also pose a competitive threat to branded biologics like INTRON A. Studies have shown that biologics facing biosimilar competition can experience price decreases, ranging from 6.6% to 66.0% depending on the drug and market conditions[3].

Regional Market Analysis

The demand for interferons varies geographically:

Key Markets

The USA, Germany, the United Kingdom, China, and Japan are among the top countries driving demand for interferons. The USA alone accounted for nearly 92.8% of the North American interferons market in 2021[1].

Regional Prevalence of Diseases

The prevalence of diseases treated by interferons also varies regionally. For example, multiple sclerosis has a higher prevalence in regions like Canada and Scotland compared to equatorial regions of Asia, Africa, and America[1].

Financial Trajectory

Current Market Valuation

As part of the broader interferons market, INTRON A contributes to the current market valuation of USD 9.4 billion in 2022. The market is expected to expand to USD 13.8 billion by 2032[1].

Revenue Growth

The growth in revenue for INTRON A and similar interferons is anticipated to be steady, driven by the increasing demand for immunotherapy drugs. The global immunotherapy drugs market, of which interferons are a part, was valued at USD 181.8 billion in 2021, with interferons holding about 5.0% of this market share[1].

Impact of Biosimilars

The entry of biosimilars could affect the revenue trajectory of INTRON A. While biosimilars may reduce prices and market share, they also offer opportunities for cost savings and increased patient access. For instance, biologics facing biosimilar competition have seen price reductions, which can lead to substantial savings for payers and patients[3].

Competitive Landscape

The interferons market is highly competitive, with several key players:

Major Players

Companies like Roche, Merck & Co., Bristol-Myers Squibb, Biogen Inc., and Bayer AG are prominent in the market. These companies are continuously investing in research and development to enhance their product portfolios and stay competitive[1].

Product Innovations

The ongoing development of novel interferon beta products, such as Biogen Inc.'s PLEGRIDY, which received FDA approval for a new intramuscular injectable route, highlights the innovative efforts in this space[1].

Financial Projections and Modeling

To project the financial health of a company like the one producing INTRON A, it is crucial to analyze the balance sheet, income statement, and cash flow statement.

Financial Statements

• Balance Sheet: Provides a snapshot of the company's assets, liabilities, and owner's equity at a specific point in time.
• Income Statement: Shows the company's revenues, expenses, and profits over a period.
• Cash Flow Statement: Details how the company used its cash during an accounting period, categorizing it into operations, investing, and financing activities[5].

Forecasting

Financial forecasting involves making strategic assumptions about future performance. For a biologic drug like INTRON A, this would include assumptions about sales growth, cost of goods sold, research and development expenses, and the impact of biosimilars on market share and pricing[5].

Key Takeaways

• The global interferons market, including INTRON A, is expected to grow at a CAGR of 3.9% from 2022 to 2032.
• The market is driven by increasing prevalence of chronic diseases and advancements in drug delivery systems.
• Biosimilar competition is a significant factor that can impact pricing and market share.
• Regional market dynamics vary, with the USA, Germany, the UK, China, and Japan being key markets.
• Financial projections must consider the impact of biosimilars, sales growth, and R&D investments.

FAQs

What is the projected market size for the global interferons market by 2032?

The global interferons market is expected to reach a valuation of USD 13.8 billion by the end of 2032[1].

How does the prevalence of multiple sclerosis impact the interferons market?

The increasing prevalence of multiple sclerosis worldwide is a significant driver for the demand of interferon-beta solutions, contributing to the growth of the interferons market[1].

What is the impact of biosimilars on the pricing of biologic drugs like INTRON A?

Biosimilars can lead to price reductions for biologic drugs, ranging from 6.6% to 66.0% depending on the drug and market conditions, offering substantial savings to payers and patients[3].

Which regions are expected to drive demand for interferons?

The USA, Germany, the United Kingdom, China, and Japan are among the top countries driving demand for interferons[1].

How do novel drug delivery systems affect the market for INTRON A?

Novel drug delivery systems and combination therapies enhance the efficacy and patient compliance of interferons, contributing to market growth and competitiveness[1].

Sources

1. Future Market Insights: Interferons Market Size, Industry Share & Trends - 2032
2. YouTube: Financial Projections for Startups Basic Walkthrough
3. Taylor & Francis Online: Estimating the impact of biosimilar entry on prices and expenditures
4. Business Wire: Global Interferons Market 2019-2023 | Technavio
5. YouTube: Financial Forecasting and Modeling 2+ Hour Course