BOTOX Drug Profile

Summary for Tradename: BOTOX

High Confidence Patents:	11
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for BOTOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BOTOX

See drug prices for BOTOX

Recent Litigation for BOTOX

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 BOTOX litigation

PTAB Litigation

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

See all BOTOX litigation

Pharmacology for BOTOX

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 BOTOX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BOTOX 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	onabotulinumtoxina	For Injection	103000		2017-07-15	Company disclosures
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2017-07-15	Company disclosures

3) Low Certainty: US Patents for BOTOX 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	onabotulinumtoxina	For Injection	103000		2033-03-11	Patent claims search
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2034-03-16	Patent claims search
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2036-03-11	Patent claims search

International Patents for BOTOX

Country	Patent Number	Estimated Expiration
Canada	2180011
Denmark	1658858
Denmark	1011695
Japan	2010209105
Japan	2005089478

Supplementary Protection Certificates for BOTOX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2013 00041	Denmark
122008000042	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
122008000043	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
92055	Luxembourg		PRODUCT NAME: TOXINE BOTULIQUE DE CLOSTRIDIUM BOTULINUM
C300564	Netherlands		PRODUCT NAME: BOTULINUM TOXINE; NAT. REGISTRATION NO/DATE: RVG 32957RVG 17379RVG 32958 2012270627; FIRST REGISTRATION: NL 25449 20110822

Botulinum Toxin (BOTOX) Market Dynamics and Financial Trajectory

Market Overview

The botulinum toxin market, commonly associated with the brand name BOTOX, is experiencing robust growth driven by its extensive applications in both therapeutic and aesthetic domains. Here are the key dynamics and financial projections for this market.

Market Size and Growth Projections

• The global botulinum toxin market is estimated to be valued at approximately $6.83 billion in 2024 and is forecasted to reach $13.14 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 6.8%[1].
• Another projection indicates the market could reach $13.4 billion by 2032, with a CAGR of 8.4% from 2023 to 2032[3].
• A more aggressive estimate suggests the market could grow to $21.6 billion by 2032, with a CAGR of 9.4% from 2024 to 2032[4].

Regional Market Performance

North America

• North America, particularly the United States, is a significant market for botulinum toxin. The U.S. market was valued at $3.98 billion in 2024 and is expected to grow to $7.93 billion by 2034, with a CAGR of 7.1%[1].
• The widespread availability of minimally invasive cosmetic surgeries and increasing approvals for Botox products are key drivers in this region.

Brazil

• Brazil is another promising market, with a valuation of $170.7 million in 2024, expected to grow to $334.2 million by 2034 at a CAGR of 7%[1].
• The high demand for cosmetic procedures and the availability of affordable treatments are driving factors in this market.

Asia Pacific

• The Asia Pacific region is also seeing significant growth, driven by an increasing demand for cosmetic procedures and the popularity of combining botulinum toxin with other treatments like dermal fillers[3].

Therapeutic and Aesthetic Applications

Therapeutic Uses

• Botulinum toxin is used for treating various medical conditions, including chronic migraines, muscle spasticity, certain eye disorders, overactive bladders, and excessive sweating (hyperhidrosis)[3][4].
• These therapeutic applications are expanding the market beyond its traditional aesthetic uses.

Aesthetic Uses

• The aesthetic sector remains a major driver, with botulinum toxin being widely used in non-surgical procedures to diminish facial wrinkles and fine lines[1][3][4].
• The growing trend of combining botulinum toxin with other treatments for enhanced and longer-lasting results is also boosting demand.

Market Trends

Combination Therapies

• The increasing popularity of combination therapies, such as using botulinum toxin with dermal fillers, is a notable trend. This approach offers enhanced effectiveness and longer-lasting results, making it attractive to patients[1][3].

Regulatory Approvals and Innovations

• Significant regulatory approvals and innovative research are contributing to the market's growth. Companies are introducing new botulinum toxins and expanding their therapeutic applications[3][4].

Mergers and Acquisitions

• Strategic mergers and acquisitions, such as AbbVie’s $10.1 billion acquisition of ImmunoGen, are aimed at enhancing therapeutic offerings and patient care through advanced treatments[3].

Financial Performance of Key Players

AbbVie

• AbbVie, a major player in the botulinum toxin market, reported global Botox Cosmetic net revenues of $718 million in 2023, an increase of 11.8% on a reported basis and 12.3% on an operational basis[2].
• In the third quarter of 2024, AbbVie reported global Botox Cosmetic net revenues of $671 million, an increase of 8.2% on a reported basis and 9.9% on an operational basis[5].

Challenges and Limitations

Counterfeit Products

• The increasing number of counterfeit products in the marketplace is a significant challenge that could limit market growth[1].

Reimbursement Issues

• Lack of proper reimbursement scenarios for treatments involving botulinum toxin is another factor that could hinder market expansion[1].

Type A Botulinum Toxin Dominance

• Type A botulinum toxin accounts for the majority of the market share, driven by its extensive use in various cosmetic and aesthetic procedures. It is expected to grow at a CAGR of 6.7% from 2024 to 2034[1].

Key Takeaways

• The botulinum toxin market is driven by both therapeutic and aesthetic applications.
• North America, particularly the U.S., and the Asia Pacific region are key markets.
• Combination therapies and regulatory approvals are significant trends.
• Major players like AbbVie are reporting strong financial performance in this sector.
• Challenges include counterfeit products and reimbursement issues.

FAQs

What is the current market size of the botulinum toxin market?

The global botulinum toxin market is estimated to be valued at approximately $6.83 billion in 2024[1].

What is the projected growth rate of the botulinum toxin market?

The market is forecasted to grow at a CAGR of 6.8% from 2024 to 2034, reaching $13.14 billion by 2034[1].

Which region dominates the botulinum toxin market?

North America, particularly the United States, holds a significant share of the market, with a projected value of $7.93 billion by 2034[1].

What are the primary applications of botulinum toxin?

Botulinum toxin is used in both therapeutic applications (e.g., chronic migraines, muscle spasticity) and aesthetic applications (e.g., diminishing facial wrinkles and fine lines)[3][4].

What are the challenges facing the botulinum toxin market?

Key challenges include the increasing number of counterfeit products and the lack of proper reimbursement scenarios for treatments involving botulinum toxin[1].

Sources

1. Fact.MR: Botulinum Toxin Market Trends | Growth Analysis 2034
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results
3. Market.US: Botulinum Toxin Market to Surge at 8.4% CAGR from 2023-2032
4. GlobeNewswire: Botulinum Toxin Market Size Projected to Reach USD 21.6 Billion by 2032 with a 9.4% CAGR
5. PR Newswire: AbbVie Reports Third-Quarter 2024 Financial Results