XOLAIR Drug Profile

Summary for Tradename: XOLAIR

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

Recent Clinical Trials for XOLAIR

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of California, Davis	Phase 3
Kashiv BioSciences, LLC	Phase 3
Kashiv BioSciences, LLC	Phase 1

See all XOLAIR clinical trials

Recent Litigation for XOLAIR

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 XOLAIR litigation

PTAB Litigation

Petitioner	Date
GEMoaB Monoclonals GmbH et al.	2019-12-20
	2017-12-20

See all XOLAIR litigation

Pharmacology for XOLAIR

Mechanism of Action	IgE-directed Antibody Interactions
Physiological Effect	Decreased IgE Activity
Established Pharmacologic Class	Anti-IgE

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 XOLAIR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for XOLAIR 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
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,011,584	2034-05-02	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,016,338	2033-03-11	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,028,940	2033-08-13	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,086,076	2026-09-08	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,111,968	2032-02-15	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,182,561	2024-12-29	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,184,001	2034-11-26	Patent claims search

XOLAIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: XOLAIR

Introduction to XOLAIR

XOLAIR (omalizumab) is a biologic drug that has revolutionized the treatment of moderate to severe persistent allergic asthma, Chronic Idiopathic Urticaria (CIU), and nasal polyps. It is specifically designed to target and block IgE, a key player in allergic reactions.

Mechanism of Action and Clinical Use

XOLAIR works by binding to IgE antibodies, preventing them from interacting with the high-affinity IgE receptor on mast cells and basophils. This mechanism reduces the release of mediators involved in allergic inflammation, providing significant relief to patients with severe allergic conditions[3].

Regulatory Milestones

XOLAIR was approved by the FDA in 2003 for the treatment of moderate to severe persistent allergic asthma. In April 2021, it received additional approval for treating CIU and nasal polyps, further expanding its clinical utility[1][4].

Market Size and Growth

The global asthma therapeutics market, in which XOLAIR plays a significant role, was estimated at USD 26.41 billion in 2023. This market is projected to grow at a CAGR of 5.30% from 2024 to 2030. The anti-inflammatory segment, led by biologics like XOLAIR, accounted for a revenue share of 62.37% in 2023[4].

Regional Dominance

North America dominated the asthma therapeutics market in 2023, accounting for a share of 51.00%. This regional dominance is partly due to the high adoption rate of innovative biologics like XOLAIR in the U.S. and other North American countries[1].

Financial Performance

The financial performance of XOLAIR has been robust. For instance, in the third quarter of 2006, U.S. sales of XOLAIR increased by 30% to $107 million compared to the same period in 2005. This growth was a result of its effectiveness and the collaborative efforts between Genentech, Tanox, and Novartis in developing and commercializing the drug[2].

Acquisition and Partnerships

In 2006, Genentech acquired Tanox for approximately $919 million, which included a 47% premium over Tanox’s closing price. This acquisition allowed Genentech to eliminate royalty payments to Tanox and gain control over Novartis’s profit share and royalty payments, thereby enhancing its financial benefits from XOLAIR[2].

Pricing and Cost Considerations

The list price of XOLAIR is approximately $30,000 to $60,000 annually, although most patients do not pay this full amount due to various insurance coverage and financial support programs. The actual cost depends on factors such as insurance coverage, diagnosed condition, and the prescribed dose and frequency[5].

Market Forecast

The market forecast for XOLAIR is positive, driven by the increasing prevalence of allergic diseases and the ongoing research and development in novel anti-inflammatory therapies. The combination therapy segment, which includes biologics like XOLAIR, is expected to register the fastest CAGR from 2024 to 2033[1].

Competitive Landscape

XOLAIR faces competition from other emerging therapies for nasal polyps and asthma. However, its established presence and continuous R&D efforts, including collaborations between pharmaceutical companies, research institutions, and healthcare organizations, help it maintain a strong market position[3][4].

Route of Administration

The inhaled route of administration segment, which is relevant to asthma treatment, led the industry in 2023 with the largest revenue share. However, the oral segment is projected to witness the highest growth rate from 2024 to 2033, indicating a potential shift in treatment preferences[1].

Research and Development

The development of XOLAIR and other anti-inflammatory biologics is driven by collaborations between pharmaceutical companies, research institutions, and healthcare organizations. These partnerships facilitate the discovery and commercialization of novel drugs, further propelling segment growth. For example, the partnership between Propeller Health and UC Davis Health aims to provide personalized medicine for patients at high risk of COPD and asthma[4].

Emerging Therapies and Challenges

The market for nasal polyps and asthma is set to change due to extensive research and incremental healthcare spending. Emerging therapies are expected to give tough competition to XOLAIR, and the launch of late-stage emerging therapies will significantly impact the market. Companies are developing novel approaches to treat and improve disease conditions, assess challenges, and seek opportunities that could influence XOLAIR's dominance[3].

SWOT Analysis

• Strengths: Established market presence, FDA approvals for multiple indications, and strong R&D collaborations.
• Weaknesses: High cost, competition from emerging therapies.
• Opportunities: Growing prevalence of allergic diseases, potential expansion into new markets.
• Threats: Regulatory changes, competition from generic or biosimilar products.

Key Takeaways

• XOLAIR is a biologic drug that targets IgE to treat severe allergic conditions.
• The drug has seen significant financial growth and is expected to continue growing due to its effectiveness and ongoing R&D efforts.
• The market is dominated by the anti-inflammatory segment, with North America leading in terms of revenue.
• Pricing is a significant factor, but financial support programs help make the drug more accessible.
• Emerging therapies pose a competitive threat, but XOLAIR’s established presence and continuous innovation help it maintain market relevance.

FAQs

What is XOLAIR used for?

XOLAIR is used to treat moderate to severe persistent allergic asthma, Chronic Idiopathic Urticaria (CIU), and nasal polyps.

How does XOLAIR work?

XOLAIR works by binding to IgE antibodies, preventing them from interacting with the high-affinity IgE receptor on mast cells and basophils.

What was the impact of Genentech's acquisition of Tanox on XOLAIR?

Genentech's acquisition of Tanox allowed it to eliminate royalty payments to Tanox and gain control over Novartis’s profit share and royalty payments, enhancing its financial benefits from XOLAIR.

How much does XOLAIR cost?

The list price of XOLAIR is approximately $30,000 to $60,000 annually, but most patients do not pay this full amount due to insurance coverage and financial support programs.

What are the future market prospects for XOLAIR?

The market prospects for XOLAIR are positive, driven by the increasing prevalence of allergic diseases and ongoing R&D efforts. However, it faces competition from emerging therapies.

Sources

1. Biospace: Asthma Therapeutics Market Size to Hit USD 45.96 Billion by 2033
2. Genetic Engineering & Biotechnology News: Genentech Spends $919M to Increase Financial Benefits from Xolair
3. Business Wire: XOLAIR Drug Insights and Market Forecasts, 2019-2021 & 2022-2032
4. Grand View Research: Asthma Therapeutics Market Size And Share Report, 2030
5. XOLAIR: XOLAIR® (omalizumab) Pricing | Cost