MYOBLOC Drug Profile

Summary for Tradename: MYOBLOC

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for MYOBLOC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYOBLOC

Recent Clinical Trials for MYOBLOC

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Solstice Neurosciences	Phase 3
Supernus Pharmaceuticals, Inc.	Phase 2/Phase 3
US WorldMeds LLC	Phase 2/Phase 3

See all MYOBLOC clinical trials

Recent Litigation for MYOBLOC

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Halozyme, Inc. v. Lee	2016-12-18

See all MYOBLOC litigation

Pharmacology for MYOBLOC

Mechanism of Action	Acetylcholine Release Inhibitors
Established Pharmacologic Class	Acetylcholine Release Inhibitor

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 MYOBLOC Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2013-12-28	Company disclosures
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2013-12-28	Company disclosures
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2013-06-10	Company disclosures
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2013-12-28	Company disclosures

3) Low Certainty: US Patents for MYOBLOC 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
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2023-10-29	Patent claims search
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2023-12-09	Patent claims search
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2033-09-20	Patent claims search
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846		2037-03-31	Patent claims search

International Patents for MYOBLOC

Country	Patent Number	Estimated Expiration
Hong Kong	1070831
Germany	69435235
European Patent Office	1147776
European Patent Office	1757325

Supplementary Protection Certificates for MYOBLOC

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132008901655481	Italy		PRODUCT NAME: NEUROTOSSINA DI CLOSTRIDIUM BOTULINUM DI TIPO A (150 KD) PRIVA DI PROTEINE COMPLESSATE(XEOMIN); AUTHORISATION NUMBER(S) AND DATE(S): 838, 20080409;57093.00.00, 20050531
132010901814274	Italy		AUTHORISATION NUMBER(S) AND DATE(S): EU/1/00/166/001-003, 20010122
122009000066	Germany		PRODUCT NAME: BOTULINUMTOXIN TYP B; REGISTRATION NO/DATE: EU/1/00/166/001-003 20010122
132008901655480	Italy		PRODUCT NAME: NEUROTOSSINA DI CLOSTRIDIUM BOTULINUM DI TIPO A (150 KD) PRIVA DI PROTEINE COMPLESSATE(XEOMIN); AUTHORISATION NUMBER(S) AND DATE(S): 838, 20080409;57093.00.00, 20050531

Market Dynamics and Financial Trajectory for Myobloc (Botulinum Toxin Type B)

Introduction to Myobloc

Myobloc, a brand of botulinum toxin type B, is a biologic drug used for various therapeutic and aesthetic purposes. It is primarily known for its application in treating neurological disorders and muscle spasms.

Market Size and Growth

The global botulinum toxin market, which includes Myobloc, is projected to experience significant growth. By 2032, the market is expected to reach $16.01 billion, growing at a CAGR of 7.9% from 2024 to 2032[1][4].

Segment Performance

• Botulinum Toxin Type B Segment: While the botulinum toxin type A segment dominates the market due to its widespread use and customer preference, the type B segment, which includes Myobloc, is anticipated to exhibit faster growth. This is driven by the expansion of therapeutic indications, such as chronic sialorrhea, and growing research into other potential uses[1][4].

Therapeutic Uses and Expansion

Current Therapeutic Applications

Myobloc is currently used to treat various conditions, including:

• Chronic Sialorrhea: Excessive salivation is a common issue in patients with neurological disorders, and Myobloc has been approved for its treatment.
• Muscle Spasms: It is effective in treating cervical dystonia and other muscle spasms.
• Neurological Disorders: Myobloc is used to treat conditions such as blepharospasm and other primary neurological disorders[4].

Future Therapeutic Potential

The market growth for Myobloc is also driven by ongoing research and development aimed at expanding its therapeutic indications. Key stakeholders, particularly after the strategic acquisition of Supernus Pharmaceuticals, Inc. by US WorldMeds LLC, are focusing on broadening the therapeutic uses of Myobloc[1].

End-User Segments

Specialty & Dermatology Clinics

The largest market share for botulinum toxin products, including Myobloc, comes from specialty and dermatology clinics. These clinics perform a significant percentage of procedures compared to hospitals, contributing to the segment's growth. The increasing number of aesthetic issues, such as frown lines and crow’s feet, further boosts demand in this segment[1].

Financial Performance of Key Players

Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, the company behind Myobloc, has shown significant financial growth:

• Revenue Increase: In 2021, Supernus reported total revenues of $579.8 million, an 11% increase from 2020. This growth was partly due to the acquisition of the CNS portfolio of US WorldMeds and the launch of new products[5].
• Net Product Sales: The net product sales for 2021 were $567.5 million, up 11% from the previous year. This increase was driven by the acquisition of Adamas Pharmaceuticals and the launch of Qelbree[5].

Financial Highlights

• Second Quarter 2022: Supernus reported total revenues of $170.1 million, a 20% increase compared to the second quarter of 2021. Operating earnings for the same period were $11.3 million[2].
• Cash and Securities: As of December 31, 2021, Supernus had approximately $458.8 million in cash, cash equivalents, and marketable securities, though this was a decrease from the previous year due to acquisition funding[5].

Competitive Environment

The botulinum toxin market is competitive, with several key players:

• Market Leaders: Companies like Allergan (now part of AbbVie) and Ipsen dominate the market with their botulinum toxin type A products. However, Supernus is positioning Myobloc for growth through strategic acquisitions and expanded therapeutic indications[1][4].

Regulatory and Reimbursement Scenario

The regulatory environment plays a crucial role in the growth of the botulinum toxin market:

• Approvals and Launches: New product approvals and launches are critical for market growth. The potential approval of Myobloc in emerging regions and for new indications will further drive its market share[1][4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the botulinum toxin market:

• Procedure Delays: The pandemic led to delays in non-essential procedures, including aesthetic treatments. However, the market has shown resilience and is recovering as restrictions ease and demand for therapeutic treatments remains strong[1].

Key Takeaways

• Market Growth: The global botulinum toxin market, including Myobloc, is expected to grow significantly, reaching $16.01 billion by 2032.
• Therapeutic Expansion: Myobloc's market growth is driven by expanding therapeutic indications and ongoing research.
• Financial Performance: Supernus Pharmaceuticals has shown strong revenue growth, partly due to strategic acquisitions and new product launches.
• Competitive Environment: The market is competitive, but Myobloc is positioned for growth through strategic moves.

FAQs

What is the projected market size for the global botulinum toxin market by 2032?

The global botulinum toxin market is projected to reach $16.01 billion by 2032, growing at a CAGR of 7.9% from 2024 to 2032[1].

What are the primary therapeutic uses of Myobloc?

Myobloc is primarily used to treat chronic sialorrhea, muscle spasms, and other neurological disorders such as cervical dystonia and blepharospasm[4].

How has the COVID-19 pandemic affected the botulinum toxin market?

The pandemic led to delays in non-essential procedures but has not significantly impacted the long-term growth trajectory of the market, which is recovering as restrictions ease[1].

What is the significance of the acquisition of US WorldMeds LLC by Supernus Pharmaceuticals?

The acquisition has contributed to the growth of Myobloc by expanding its therapeutic uses and increasing its market presence through strategic moves[1].

Which segment dominates the botulinum toxin market?

The specialty and dermatology clinics segment accounts for the largest market share due to the high number of procedures performed in these settings[1].

Sources

1. Fortune Business Insights: "Botulinum Toxin Market Size | Global Growth Report [2032]"
2. Supernus Pharmaceuticals: "Supernus Announces Second Quarter 2022 Financial Results"
3. BCC Research: "Biologic Therapeutic Drugs: Technologies and Global Markets"
4. Allied Market Research: "Botulinum Toxin Market Size, Share | Growth Report - 2031"
5. GlobeNewswire: "Supernus Announces Preliminary Fourth Quarter and Full Year 2021 Financial Results"