Onabotulinumtoxina - Biologic Drug Details

Summary for onabotulinumtoxina

Tradenames:	2
High Confidence Patents:	11
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for onabotulinumtoxina
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for onabotulinumtoxina

Recent Clinical Trials for onabotulinumtoxina

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of New Mexico	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4
University of California, San Diego	Phase 4

See all onabotulinumtoxina clinical trials

Recent Litigation for onabotulinumtoxina

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Grant Prideco, Inc. v. Schlumberger Technology Corporation	2023-02-27
Teva Pharmaceuticals International GmbH v. Eli Lilly and Company	2021-06-07

See all onabotulinumtoxina litigation

PTAB Litigation

Petitioner	Date
Candela Corporation et al.	2022-11-18
Eli Lilly and Company	2022-04-11
	2017-02-21

See all onabotulinumtoxina litigation

Pharmacology for onabotulinumtoxina

Mechanism of Action	Acetylcholine Release Inhibitors
Physiological Effect	Neuromuscular Blockade
Established Pharmacologic Class	Acetylcholine Release Inhibitor Neuromuscular Blocker

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 onabotulinumtoxina Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2017-07-15	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures

3) Low Certainty: US Patents for onabotulinumtoxina 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
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2033-03-11	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2034-03-16	Patent claims search

International Patents for onabotulinumtoxina

Country	Patent Number	Estimated Expiration
Portugal	1725253
Japan	2015071638
Japan	2008037877
Mexico	337511

Supplementary Protection Certificates for onabotulinumtoxina

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2013 00041	Denmark
122012000065	Germany		PRODUCT NAME: BOTULINUMTOXIN; NAT. REGISTRATION NO/DATE: 55006.00.00 74281.00.00 80457.00.00 20110920 FIRST REGISTRATION: FRANKREICH NL 25449 NL 32017 NL 32018 20110822
300654	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
2013C/047	Belgium		PRODUCT NAME: TOXINE BOTULIQUE TYPE A; AUTHORISATION NUMBER AND DATE: 215126BE 20130128

Botulinum Toxin Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction

The botulinum toxin market, particularly driven by the popular biologic drug onabotulinumtoxinA (commonly known as Botox), is experiencing significant growth and transformation. This article delves into the market dynamics, financial trajectory, and key factors influencing the botulinum toxin market.

Market Size and Growth Projections

The global botulinum toxin market is substantial and growing rapidly. As of 2022, the market size was valued at approximately $5.9 billion, with projections indicating it will reach $12.6 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 7.1%[1][3][4].

Regional Market Share

North America dominates the global botulinum toxin market, holding a significant market share. In 2023, North America accounted for around 66.34% of the global market, driven by the high acceptance of botulinum toxin procedures and the presence of major companies in the region[4].

United States and United Kingdom

The United States and the United Kingdom are expected to lead the market, with the UK market projected to expand at a CAGR of 6.2% over the forecast period. India is also set to experience rapid growth, with a CAGR of 8.1%[1].

Asia-Pacific and Latin America

The Asia-Pacific region is forecasted to experience the fastest CAGR between 2023 and 2032, while Latin America and Japan will hold smaller but significant market shares of around 4.2% and 3.1%, respectively[1][3].

Product Segments

The botulinum toxin market is segmented into Type A and Type B products.

Type A Segment

The Type A segment, which includes onabotulinumtoxinA, is expected to hold the largest market value, with a revenue share of around 43.7% in the global medical aesthetics market. This segment is driven by its widespread use in both aesthetic and therapeutic applications[1].

Type B Segment

The Type B segment, though smaller, is expected to grow, particularly after strategic acquisitions and expansions in therapeutic uses. For example, the acquisition of Supernus Pharmaceuticals, Inc. by USWM, LLC, is expected to boost the growth of Myobloc (a Type B botulinum toxin product)[4].

Applications and End-Users

The market is segmented into aesthetic and therapeutic applications, with each segment having distinct end-users.

Therapeutic Applications

The therapeutic segment is the frontrunner, driven by the treatment of conditions such as blepharospasm, chronic migraine, overactive bladder, spasticity, and cervical dystonia. Investments in R&D and regulatory approvals for diverse diseases are key drivers of this segment's growth[3][4].

Aesthetic Applications

Aesthetic applications, including procedures for frown lines, Glabellar Lines, and Crow’s Feet, are also significant. Specialty and dermatology clinics account for the largest market share in this segment due to the high volume of procedures performed in these settings[4].

Key Players and Product Launches

Companies like AbbVie Inc. and Revance Therapeutics, Inc. are driving market growth through innovative product launches and strategic initiatives.

Revance Therapeutics

Revance Therapeutics' product DAXXIFY, a long-lasting peptide-formulated neuromodulator, has seen robust growth, with a 22% increase in volume sold in Q4 2023 compared to the previous quarter. The company projects significant revenue growth and expects to achieve positive Adjusted EBITDA by 2025[2].

AbbVie Inc.

AbbVie Inc.'s presentations at the European Headache Federation Congress 2022 highlighted its research on migraine treatments, including onabotulinumtoxinA. Such research and product launches are crucial for expanding the therapeutic uses of botulinum toxin[4].

Financial Outlook

The financial trajectory of the botulinum toxin market is promising, with several factors contributing to its growth.

Revenue Growth

The market is expected to grow from $8.14 billion in 2023 to $16.01 billion by 2032, at a CAGR of 7.9%[4].

Cost Management and Profitability

Companies are focusing on cost management and profitability. For instance, Revance Therapeutics expects to reduce its GAAP and non-GAAP operating expenses in 2024 and achieve positive Adjusted EBITDA by 2025 through strategic cost management and the exit from non-core businesses[2].

Market Drivers

Several factors are driving the growth of the botulinum toxin market.

Aging Population

The increasing life expectancy and aging population have led to a greater emphasis on aesthetics and physical attractiveness, driving demand for Botox treatments[1].

Therapeutic Uses

The expansion of therapeutic uses, particularly in treating conditions like chronic migraine and cervical dystonia, has significantly boosted the market. For example, Botox injections have been shown to reduce migraine frequency and duration[1].

Regulatory Approvals

Regulatory approvals for new indications and products are crucial for market growth. The approval of DAXXIFY for cervical dystonia and the expansion of indications for the RHA Collection are expected to contribute to future growth[2].

Market Challenges

Despite the growth, the market faces several challenges.

Regulatory and Trade Policies

Changes in trade policies, import-export regulations, and international tariffs can influence the market's stability and growth trajectories. Strategic initiatives like mergers, acquisitions, and partnerships are essential to navigate these challenges[3].

Economic Factors

Macroeconomic factors, such as supply chain disruptions and end-user demand fluctuations, can impact the market. Companies must be agile and responsive to these changes to maintain growth[2].

Key Takeaways

• Market Size and Growth: The global botulinum toxin market is projected to grow from $5.9 billion in 2022 to $12.6 billion by 2033 at a CAGR of 7.1%.
• Regional Dominance: North America, particularly the United States, holds the largest market share.
• Product Segments: Type A segment dominates, with Type B segment expected to grow through strategic acquisitions and expansions.
• Applications: Therapeutic applications are the frontrunner, driven by treatments for various medical conditions.
• Financial Outlook: Companies are focusing on cost management and profitability, with projections indicating significant revenue growth.
• Market Drivers: Aging population, therapeutic uses, and regulatory approvals are key drivers of the market.

FAQs

What is the projected market size of the botulinum toxin market by 2033?

The global botulinum toxin market is projected to reach $12.6 billion by 2033[1].

Which region dominates the botulinum toxin market?

North America, particularly the United States, dominates the global botulinum toxin market[4].

What are the primary applications of botulinum toxin?

The primary applications are aesthetic and therapeutic, with therapeutic uses being the dominant segment[3][4].

Which companies are key players in the botulinum toxin market?

Key players include AbbVie Inc. and Revance Therapeutics, Inc., among others[2][4].

What are the major drivers of the botulinum toxin market?

The major drivers include the aging population, expansion of therapeutic uses, and regulatory approvals for new indications and products[1][3][4].

Sources

1. Persistence Market Research: "Botulinum Toxin Market Size, Share, & Growth Report, 2033"[1]
2. Stocktitan: "Revance Provides Corporate Update, Preliminary Fourth Quarter"[2]
3. Pharmiweb: "Botulinum Toxin Market Predicted USD 13.4 Billion By 2032, An Approximate 8.4% CAGR Growth"[3]
4. Fortune Business Insights: "Botulinum Toxin Market Size | Global Growth Report [2032]"[4]