Dantrolene sodium - Generic Drug Details

What are the generic drug sources for dantrolene sodium and what is the scope of patent protection?

Dantrolene sodium is the generic ingredient in four branded drugs marketed by Endo Operations, Elite Labs Inc, Impax Labs, Eagle Pharms, Eugia Pharma Speclts, Hikma, and Uswm, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Dantrolene sodium has eight patent family members in five countries.

There are five drug master file entries for dantrolene sodium. Twelve suppliers are listed for this compound.

Summary for dantrolene sodium

International Patents:	8
US Patents:	1
Tradenames:	4
Applicants:	7
NDAs:	8
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	2
Patent Applications:	11
Drug Prices:	Drug price trends for dantrolene sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dantrolene sodium
What excipients (inactive ingredients) are in dantrolene sodium?	dantrolene sodium excipients list
DailyMed Link:	dantrolene sodium at DailyMed

See drug prices for dantrolene sodium

Recent Clinical Trials for dantrolene sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 2
National Institutes of Health (NIH)	Phase 1/Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1/Phase 2

See all dantrolene sodium clinical trials

Pharmacology for dantrolene sodium

Drug Class	Skeletal Muscle Relaxant
Physiological Effect	Decreased Striated Muscle Contraction Decreased Striated Muscle Tone

Medical Subject Heading (MeSH) Categories for dantrolene sodium

Muscle Relaxants, Central

Anatomical Therapeutic Chemical (ATC) Classes for dantrolene sodium

M03CA	Dantrolene and derivatives
M03C	MUSCLE RELAXANTS, DIRECTLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

US Patents and Regulatory Information for dantrolene sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Uswm	REVONTO	dantrolene sodium	INJECTABLE;INJECTION	078378-001	Jul 24, 2007	AP	RX	No	No
Elite Labs Inc	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076686-001	Oct 24, 2005	AB	RX	No	No
Hikma	DANTROLENE SODIUM	dantrolene sodium	INJECTABLE;INJECTION	204762-001	Jun 19, 2017	AP	RX	No	No

Expired US Patents for dantrolene sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	8,604,072
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	3,415,821
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	9,884,044

International Patents for dantrolene sodium

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005013919
European Patent Office	1435781
Australia	2004262507

Dantrolene sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dantrolene Sodium

Introduction

Dantrolene sodium, a critical skeletal muscle relaxant, is experiencing significant growth in the global pharmaceutical market. This article delves into the market dynamics, financial trajectory, and the various factors influencing the demand and supply of dantrolene sodium.

Market Growth Drivers

The dantrolene sodium market is primarily driven by several key factors:

Increasing Incidence of Malignant Hyperthermia

Malignant hyperthermia, a rare but potentially fatal condition triggered by certain anesthetic agents, is on the rise. The growing incidence of this disorder has led to an increased demand for dantrolene sodium, which is the only specific treatment for malignant hyperthermia[1][2][4].

Expanding Therapeutic Applications

Beyond malignant hyperthermia, dantrolene sodium is also used in the management of other conditions such as neuroleptic malignant syndrome and muscle spasticity. This broader therapeutic application is further driving the market's growth[1][4].

Advancements in Formulations and Delivery Systems

Ongoing research and development efforts are focused on improving the formulations and delivery systems of dantrolene sodium. This includes the development of nanocrystalline dantrolene sodium suspensions and advanced drug delivery systems like sustained-release and intravenous formulations, enhancing the drug's efficacy and convenience[3][4].

Regional Market Dynamics

North America

North America, particularly the United States, is a leading market for dantrolene sodium. The region's well-established healthcare infrastructure, availability of reimbursement for specialized medications, and the presence of key market players contribute to its significant market share[1][4].

Europe

Europe is another prominent region, with countries like Germany, the UK, and France playing important roles. The increasing incidence of malignant hyperthermia and the growing adoption of dantrolene sodium for muscle spasm management drive the market in this region[1][4].

Asia-Pacific

The Asia-Pacific region is expected to experience the fastest growth, driven by increasing awareness about malignant hyperthermia, expanding healthcare systems, and the growing burden of muscle-related disorders in countries like China, India, and Japan[1][4].

Latin America and Middle East & Africa

These regions also present growth opportunities, supported by improving healthcare facilities and increasing investments in the healthcare sector. However, the availability and affordability of dantrolene sodium can vary significantly across these regions[4].

Competitive Landscape

The dantrolene sodium market is characterized by the presence of both established pharmaceutical companies and generic drug manufacturers. This mix contributes to a competitive landscape and ensures the availability of affordable treatment options. Companies are employing strategies such as product portfolio diversification, strategic partnerships, and targeted marketing campaigns to maintain their competitive edge[1][4].

Financial Trajectory

Cost-Effectiveness

Studies have shown that stocking dantrolene sodium in ambulatory surgery centers is cost-effective. For instance, a cost-effectiveness analysis indicated that stocking dantrolene could save 33 lives per year at an incremental cost-effectiveness ratio of nearly $200,000 per life saved, highlighting the financial benefits of having this drug readily available[2].

Market Size and Growth

The global dantrolene sodium market is expected to witness exponential growth at a significant CAGR from 2024 to 2033. The market size is driven by the increasing demand for effective muscle relaxant therapies and the ongoing recognition of dantrolene sodium's role in treating malignant hyperthermia and other muscle-related disorders[1][4].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as the low incidence of malignant hyperthermia, potential adverse effects, and evolving regulatory landscapes. However, these challenges also present opportunities for market players to innovate and expand their product portfolios, particularly in emerging markets[1][4].

Technological and Research Advancements

Technological advancements in drug delivery systems and ongoing research to explore new therapeutic applications of dantrolene sodium are crucial for the market's expansion. These efforts aim to improve the safety profiles and efficacy of dantrolene sodium, making it more appealing to healthcare providers and patients[3][4].

Impact of Digital Health Solutions

The increasing emphasis on personalized and patient-centric approaches to medical treatment, along with the growing adoption of digital health solutions, may also shape the future of the dantrolene sodium market. Digital health solutions can enhance patient outcomes, improve drug adherence, and streamline healthcare delivery, further driving the market's growth[1].

Key Takeaways

• The dantrolene sodium market is driven by the increasing incidence of malignant hyperthermia and expanding therapeutic applications.
• North America and Europe are leading markets, with the Asia-Pacific region expected to experience the fastest growth.
• The market is characterized by a mix of established and generic drug manufacturers, ensuring competitive pricing and availability.
• Technological advancements and research efforts are key to improving formulations and expanding market reach.
• Despite challenges, the market presents significant opportunities for growth and innovation.

Frequently Asked Questions (FAQs)

Q: What is the primary use of dantrolene sodium? A: Dantrolene sodium is primarily used as the only specific treatment for malignant hyperthermia, a rare but potentially fatal condition triggered by certain anesthetic agents[1][2].

Q: Which regions are expected to drive the growth of the dantrolene sodium market? A: The Asia-Pacific region is expected to experience the fastest growth, followed by emerging markets in Latin America and the Middle East & Africa[1][4].

Q: What are the key challenges facing the dantrolene sodium market? A: The market faces challenges such as the low incidence of malignant hyperthermia, potential adverse effects, and evolving regulatory landscapes[1][4].

Q: How is the cost-effectiveness of dantrolene sodium evaluated? A: Studies have shown that stocking dantrolene sodium in ambulatory surgery centers is cost-effective, saving lives at an incremental cost-effectiveness ratio of nearly $200,000 per life saved[2].

Q: What role do technological advancements play in the dantrolene sodium market? A: Technological advancements in drug delivery systems and ongoing research to improve formulations are crucial for the market's expansion, enhancing the safety and efficacy of dantrolene sodium[3][4].

Cited Sources:

1. DataHorizon Research: Dantrolene Sodium Market Size, Share, Growth, Statistics Report 2033.
2. Malignant Hyperthermia Association of the United States: Experts Say Stocking the Drug Dantrolene Saves Lives and Money.
3. Taylor & Francis Online: Do we foresee new emerging drugs to treat malignant hyperthermia?
4. MarkWide Research: Dantrolene sodium Market 2024-2032 | Size, Share, Growth.