AVONEX Drug Profile

Summary for Tradename: AVONEX

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for AVONEX
Recent Clinical Trials:	See clinical trials for AVONEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVONEX

See drug prices for AVONEX

Recent Clinical Trials for AVONEX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Merck KGaA, Darmstadt, Germany	Phase 3
EMD Serono Research & Development Institute, Inc.	Phase 3
Cinnagen	Phase 1

See all AVONEX clinical trials

Recent Litigation for AVONEX

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Amgen Inc. v. Accord Healthcare, Inc.	2018-06-28
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.	2014-07-01

See all AVONEX litigation

Pharmacology for AVONEX

Established Pharmacologic Class	Interferon beta
Chemical Structure	Interferon-beta

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 AVONEX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AVONEX Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for AVONEX 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
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,085,955	2033-01-08	Patent claims search
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,105,356	2031-01-31	Patent claims search
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,213,420	2034-02-05	Patent claims search
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,233,171	2032-04-02	Patent claims search
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,265,291	2035-07-15	Patent claims search
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,273,252	2036-04-28	Patent claims search
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	10,293,030	2036-02-29	Patent claims search

AVONEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: AVONEX

Introduction

AVONEX, a biologic drug developed by Biogen, is a key treatment for relapsing forms of multiple sclerosis (MS). Understanding the market dynamics and financial trajectory of AVONEX is crucial for investors, healthcare professionals, and industry analysts.

Market Size and Forecast

The global market for AVONEX has undergone significant changes in recent years. As of 2023, the market was estimated to be worth US$ 1.324 billion. However, it is forecast to decline to US$ 1.0629 billion by 2030, reflecting a Compound Annual Growth Rate (CAGR) of -3.1% during the forecast period of 2024-2030[1].

Key Players

Biogen and CinnaGen are the primary players in the AVONEX market. Biogen, as the original developer and marketer, holds a dominant position, while CinnaGen also plays a significant role, particularly in certain regions[1].

Historical Sales Performance

Historically, AVONEX has been a high-performing product for Biogen. In 2003, for example, AVONEX sales reached $1.168 billion, with U.S. sales accounting for $800 million and international sales totaling $368 million. This represented a 13% increase over the prior year[3].

Revenue Trends

The revenue from AVONEX has fluctuated over the years due to various factors, including market competition, regulatory changes, and manufacturing challenges. In the fourth quarter of 2003, AVONEX sales increased by 21% compared to the same period in 2002, contributing significantly to Biogen's overall revenue[3].

Impact of Multiple Sclerosis Market

The global interferon beta drugs market, which includes AVONEX, is influenced by the increasing prevalence of multiple sclerosis. This market was valued at USD 4 billion in 2021 and is expected to grow to USD 5.5 billion by 2030, with a CAGR of 3.9% from 2022 to 2030. However, AVONEX's share within this market is declining due to competition from other interferon beta drugs like Extavia, Betaseron, Plegridy, and Rebif[4].

Competitive Landscape

The interferon beta drugs market is highly competitive, with several major players including Biogen, Bayer, Hoffmann-La Roche Ltd, Merck KGaA, Novartis AG, and Pfizer Inc. The market is segmented by product type, source of administration, end-user, and geography. North America dominates the market, but the Asia-Pacific region is exhibiting the fastest growth[4].

Financial Performance of Biogen

Biogen's overall financial performance has a direct impact on the trajectory of AVONEX. In 2021, Biogen reported total revenue of $10,982 million, with multiple sclerosis (MS) revenue, including AVONEX, contributing $7,088 million. However, this represented an 18% decrease from the prior year, reflecting broader market and competitive pressures[2].

Manufacturing and Supply Challenges

The production and supply of AVONEX have faced challenges in the past. For instance, Biogen encountered manufacturing issues that led to the write-down of several batches, potentially disrupting the supply chain. Such challenges can impact the financial performance and market share of AVONEX[3].

Regional Performance

AVONEX sales vary significantly by region. Historically, U.S. sales have been a major contributor, but international sales also play a crucial role. However, regional performance can be affected by factors such as reimbursement policies, pricing decisions, and local market competition[3].

Future Outlook

Despite the forecasted decline, AVONEX remains a significant product in the MS treatment landscape. Biogen's long-term growth strategy includes the successful development and commercialization of new products, which could mitigate the decline in AVONEX sales. However, the market will continue to be influenced by increasing competition, regulatory changes, and advancements in MS treatments[3].

Key Takeaways

• Market Size: The global AVONEX market is forecast to decline to US$ 1.0629 billion by 2030.
• Key Players: Biogen and CinnaGen are the main players in the AVONEX market.
• Historical Performance: AVONEX has historically been a high-performing product, but recent years have seen a decline.
• Competitive Landscape: The interferon beta drugs market is highly competitive, with multiple major players.
• Regional Performance: Sales vary by region, influenced by local market dynamics.
• Future Outlook: The market will be shaped by competition, regulatory changes, and new product developments.

FAQs

What is the forecasted market size of AVONEX by 2030?

The forecasted market size of AVONEX by 2030 is US$ 1.0629 billion[1].

Who are the main players in the AVONEX market?

The main players in the AVONEX market are Biogen and CinnaGen[1].

What is the historical sales performance of AVONEX?

In 2003, AVONEX sales reached $1.168 billion, with a 13% increase over the prior year[3].

How does the multiple sclerosis market impact AVONEX sales?

The increasing prevalence of multiple sclerosis drives the demand for interferon beta drugs, but AVONEX's share is declining due to competition from other drugs[4].

What are the key challenges facing AVONEX production and supply?

Manufacturing issues and supply chain disruptions have been significant challenges in the past[3].

Sources

1. Valuates Reports: Avonex - Market, Report Size, Worth, Revenue, Growth, Industry...
2. Biogen Investor Relations: Biogen Reports Fourth Quarter and Full Year 2021 Results
3. Biogen Investor Relations: Untitled - Biogen | Investor Relations
4. Acumen Research and Consulting: Interferon Beta Drugs Market Size, Share and Analysis | Forecast
5. Biogen Investor Relations: BIOGEN IDEC INC.