REBIF Drug Profile

Summary for Tradename: REBIF

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for REBIF
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REBIF

See drug prices for REBIF

Recent Litigation for REBIF

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 REBIF litigation

Pharmacology for REBIF

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 REBIF Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for REBIF 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
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2033-01-08	Patent claims search
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2031-01-31	Patent claims search
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2034-02-05	Patent claims search
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2032-04-02	Patent claims search
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2035-07-15	Patent claims search
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2036-04-28	Patent claims search
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780		2036-02-29	Patent claims search

REBIF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Rebif

Introduction

Rebif, a brand of interferon beta-1a, is a biologic drug used primarily in the treatment of multiple sclerosis (MS). Developed by Merck KGaA, Rebif has been a significant player in the MS therapeutic market. However, the market dynamics and financial trajectory of Rebif have undergone significant changes due to various factors.

Historical Context and Approval

Rebif was approved by the FDA in 2002 for the treatment of relapsing forms of multiple sclerosis. It has been widely used as an injectable therapy to reduce the frequency of clinical exacerbations and slow the accumulation of physical disability.

Market Performance

Historically, Rebif has been one of the leading drugs in the MS market. However, its sales have been impacted by the introduction of newer, more convenient therapies.

Sales Trends

In recent years, Rebif's sales have declined due to increased competition from next-generation MS drugs. For instance, in the third quarter of 2019, Rebif's sales dropped by 15.1% year-over-year to €318 million ($350 million) at unchanged currencies[2].

Competitive Landscape

The MS market has become increasingly crowded with the launch of new oral and injectable therapies. Drugs like Merck KGaA's Mavenclad, Biogen's Vumerity, and Novartis' Mayzent have gained significant traction, posing a challenge to Rebif's market share. Mavenclad, for example, saw a 45% increase in sales over the previous quarter, offsetting the decline in Rebif sales[2].

Factors Influencing Market Dynamics

Biosimilar Competition

While Rebif itself is not yet facing direct biosimilar competition, the broader biologic market is experiencing price pressures due to biosimilar entries. Biologics facing biosimilar competition often see price decreases, which can impact the overall market dynamics and pricing strategies for branded biologics like Rebif[3].

Regulatory and Patent Environment

The patent landscape plays a crucial role in the biologic drug market. As patents expire, biosimilars can enter the market, potentially reducing the sales of branded drugs. Although Rebif's patent status has not been directly impacted by biosimilar entries, the general trend in the biologic market suggests that patent expiry can lead to significant market shifts[3].

Patient Preferences and Healthcare Trends

Patient preferences are shifting towards more convenient and better-tolerated therapies. Oral MS drugs like Mavenclad and Vumerity are gaining popularity due to their ease of administration compared to injectable therapies like Rebif. This shift in patient preference is a significant factor influencing the financial trajectory of Rebif[2].

Financial Trajectory

Revenue Decline

The decline in Rebif's sales is a clear indicator of its challenging financial trajectory. Despite being a well-established drug, Rebif's revenue has been impacted by the introduction of newer therapies and changing patient preferences.

Offset by Other Products

Merck KGaA has managed to offset some of the decline in Rebif sales with the success of other products, such as Mavenclad. This strategy of diversifying the product portfolio helps mitigate the financial impact of declining sales in one segment[2].

Regional Market Performance

North America

In North America, which is a significant market for MS therapies, Rebif's sales have been affected by the same competitive pressures seen globally. The region's market is driven by frequent healthcare awareness programs and a high prevalence of MS, but newer drugs are capturing a larger share of this market[1].

Europe and Asia

In Europe, the geriatric population's demand for biological drugs, including those for MS, continues to grow. However, Rebif's performance in this region is also influenced by the introduction of newer therapies. In Asia, the lower cost of drug manufacturing and encouraging government initiatives are attracting more biotech companies, but this has not significantly impacted Rebif's sales trajectory[1].

Future Outlook

Competitive Pressure

The future outlook for Rebif remains challenging due to the competitive pressure from newer, more convenient therapies. As more oral and injectable MS drugs enter the market, Rebif's market share is likely to continue declining.

Innovation and Diversification

To counter this trend, Merck KGaA and other pharmaceutical companies are investing in research and development to bring new therapies to the market. Diversifying their product portfolios and collaborating with other organizations are key strategies to maintain market presence and financial stability[5].

Key Takeaways

• Rebif's sales have declined due to competition from newer MS therapies.
• The introduction of biosimilars and changing patient preferences are significant market dynamics.
• Merck KGaA is offsetting Rebif's decline with the success of other products like Mavenclad.
• Regional markets, especially North America and Europe, are influenced by healthcare awareness and demographic changes.
• The future outlook for Rebif is challenging, with a need for innovation and diversification to maintain market share.

FAQs

Q: What is Rebif used for? A: Rebif is used for the treatment of relapsing forms of multiple sclerosis (MS).

Q: Why are Rebif's sales declining? A: Rebif's sales are declining due to increased competition from newer, more convenient MS therapies and changing patient preferences.

Q: How is Merck KGaA offsetting the decline in Rebif sales? A: Merck KGaA is offsetting the decline in Rebif sales with the success of other products, such as Mavenclad.

Q: What impact do biosimilars have on the biologic drug market? A: Biosimilars can lead to price decreases and changes in market dynamics, potentially affecting the sales of branded biologic drugs like Rebif.

Q: Which regions are most affected by the decline in Rebif sales? A: North America and Europe are significantly impacted by the decline in Rebif sales due to competitive pressures and changing patient preferences.

Sources

1. Persistence Market Research: Global Market Study On Biological Drugs.
2. FiercePharma: In crowded MS market, Merck KGaA's Mavenclad now offsets Rebif decline.
3. Taylor & Francis Online: Estimating the impact of biosimilar entry on prices and expenditures.
4. Coherent Market Insights: Interferon Beta Drugs Market Size, Trends and Forecast to 2030.
5. BioSpace: Multiple Sclerosis Therapeutic Market Size to Hit USD 46.44 Bn by 2033.