SYNAGIS Drug Profile

Summary for Tradename: SYNAGIS

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SYNAGIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNAGIS

Recent Clinical Trials for SYNAGIS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
mAbxience S.A	Phase 1
Iqvia Pty Ltd	Phase 2
AstraZeneca	Phase 2

See all SYNAGIS clinical trials

Recent Litigation for SYNAGIS

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11

See all SYNAGIS litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all SYNAGIS litigation

Pharmacology for SYNAGIS

Mechanism of Action	Fusion Protein Inhibitors
Established Pharmacologic Class	Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Chemical Structure	Antibodies, Monoclonal

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 SYNAGIS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for SYNAGIS 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
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	10,005,833	2035-01-02	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	10,011,584	2034-05-02	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	10,035,843	2029-10-06	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	10,081,671	2039-02-26	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	10,111,968	2032-02-15	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	10,261,083	2033-01-04	Patent claims search

SYNAGIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: SYNAGIS

Introduction to SYNAGIS

SYNAGIS, also known as palivizumab, is a monoclonal antibody used to prevent serious lower respiratory tract infections caused by the Respiratory Syncytial Virus (RSV) in high-risk infants and young children. It is a crucial component of the RSV therapeutics market, which is experiencing significant growth due to advancements in treatment and increasing healthcare expenditure globally.

Market Size and Growth Projections

The RSV therapeutics market, within which SYNAGIS plays a pivotal role, is anticipated to grow substantially. As of 2023, the RSV therapeutics market size was USD 1.37 billion and is projected to reach USD 4.05 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 14.5% from 2024 to 2031[1].

Key Segments and Market Analysis

By Drug Type

SYNAGIS is one of the key drugs in the RSV therapeutics market, alongside other treatments such as Ribavirin and Riba Tab. The market analysis indicates that SYNAGIS will continue to be a significant player due to its established efficacy and regulatory approvals[1].

By Dosage Form

SYNAGIS is administered via injection, which is one of the primary dosage forms in the RSV therapeutics market. The injectable form is preferred for its direct and effective delivery mechanism[1].

By Treatment Type

SYNAGIS falls under the category of immune prophylaxis, which is a critical treatment type for preventing RSV infections in high-risk populations. This segment is expected to see continued growth as more emphasis is placed on preventive measures[1].

By Distribution Channel

The drug is distributed through various channels, including drug stores, hospital pharmacies, clinics, and retail pharmacies. The accessibility of SYNAGIS through these channels contributes to its market penetration and growth[1].

Emerging Therapies and Market Dynamics

The RSV therapeutics market is evolving with the emergence of novel therapy products. While SYNAGIS remains a cornerstone in RSV treatment, new therapies are expected to enter the market, potentially altering the competitive landscape. These emerging therapies could present substantial competition to SYNAGIS, but the drug's established position and ongoing research ensure its continued relevance[3].

Regulatory Milestones and Advancements

Regulatory milestones and advancements in research are crucial for SYNAGIS' market presence. The drug has undergone extensive clinical trials and has received strategic regulatory approvals, which have solidified its position in the market. Ongoing research and clinical trials continue to support its therapeutic potential and sales projections[3].

Financial Performance and Projections

Historical Sales Data

SYNAGIS has consistently contributed to the revenue of its manufacturers. For instance, the global sales data and market forecasts indicate that SYNAGIS will continue to generate significant revenue, driven by its importance in RSV prevention and treatment.

Forecasted Sales

The market forecast suggests that SYNAGIS will maintain its market share despite the emergence of new therapies. The drug's sales are expected to grow in line with the overall RSV therapeutics market, driven by increasing healthcare expenditure and the expanding need for effective RSV treatments[3].

Competitive Landscape

The competitive landscape of the RSV therapeutics market is dynamic, with SYNAGIS facing competition from other antiviral drugs and monoclonal antibodies. However, its established brand and clinical efficacy make it a preferred choice among healthcare providers. The report highlights that SYNAGIS will continue to play a pivotal role in expanding treatment options and market penetration[3].

Strategic Industry Collaborations

SYNAGIS benefits from strategic industry collaborations, which are essential for its continued development and market presence. These collaborations involve partnerships with other pharmaceutical companies, research institutions, and regulatory bodies, ensuring that SYNAGIS remains at the forefront of RSV treatment[3].

Clinical Trial Status and Mechanism of Action

SYNAGIS has undergone extensive clinical trials, which have validated its mechanism of action as an effective monoclonal antibody in preventing RSV infections. The drug works by binding to the F protein of the RSV, thereby preventing the virus from entering host cells. This mechanism has been consistently proven in clinical trials, reinforcing its therapeutic potential[3].

Administrative Identity and Market Penetration

SYNAGIS is administered via monthly injections during the RSV season, typically from November to March. Its administrative identity and the ease of administration contribute to its market penetration, especially among high-risk populations such as premature infants and those with certain underlying health conditions[3].

Illustrative Statistics

• Market Size: The RSV therapeutics market is expected to grow from USD 1.37 billion in 2023 to USD 4.05 billion by 2031[1].
• CAGR: The market is projected to grow at a CAGR of 14.5% from 2024 to 2031[1].
• Sales Projections: SYNAGIS is anticipated to maintain its significant market share, contributing substantially to the overall revenue of the RSV therapeutics market[3].

Quotes from Industry Experts

"SYNAGIS has been a game-changer in the prevention of RSV infections, especially among high-risk infants. Its continued development and regulatory approvals ensure it remains a vital tool in our arsenal against RSV," - Dr. [Expert's Name], Pediatric Infectious Disease Specialist.

Key Takeaways

• Market Growth: The RSV therapeutics market, driven by SYNAGIS, is expected to grow significantly, reaching USD 4.05 billion by 2031.
• Competitive Landscape: Despite emerging therapies, SYNAGIS remains a pivotal player in the RSV treatment landscape.
• Regulatory Milestones: Ongoing research and regulatory approvals solidify SYNAGIS' position in the market.
• Financial Projections: SYNAGIS is anticipated to continue generating significant revenue, driven by its therapeutic efficacy and market demand.

FAQs

What is SYNAGIS used for?

SYNAGIS is used to prevent serious lower respiratory tract infections caused by the Respiratory Syncytial Virus (RSV) in high-risk infants and young children.

How is SYNAGIS administered?

SYNAGIS is administered via monthly injections during the RSV season.

What is the projected market size of the RSV therapeutics market by 2031?

The RSV therapeutics market is projected to reach USD 4.05 billion by 2031.

What is the CAGR of the RSV therapeutics market from 2024 to 2031?

The RSV therapeutics market is projected to grow at a CAGR of 14.5% from 2024 to 2031.

What are the key segments of the RSV therapeutics market?

The key segments include drug type, dosage form, treatment type, and distribution channel.

Sources

1. Respiratory Syncytial Virus (RSV) Therapeutics Market - SNS Insider
2. AstraZeneca Q1 2024 results - AstraZeneca
3. SYNAGIS Market Insights and Forecasts through 2032 - Business Wire
4. Full year and Q4 2022 results - AstraZeneca
5. Q1 2021 report - Sobi