DANTRIUM Drug Patent Profile

Which patents cover Dantrium, and what generic alternatives are available?

Dantrium is a drug marketed by Endo Operations and is included in two NDAs.

The generic ingredient in DANTRIUM is dantrolene sodium. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dantrium

A generic version of DANTRIUM was approved as dantrolene sodium by IMPAX LABS on March 1^st, 2005.

Summary for DANTRIUM

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	2
Patent Applications:	1,594
Drug Prices:	Drug price information for DANTRIUM
What excipients (inactive ingredients) are in DANTRIUM?	DANTRIUM excipients list
DailyMed Link:	DANTRIUM at DailyMed

See drug prices for DANTRIUM

Recent Clinical Trials for DANTRIUM

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 2
American Heart Association	Phase 1/Phase 2
University of Massachusetts, Worcester	Phase 1/Phase 2

See all DANTRIUM clinical trials

Pharmacology for DANTRIUM

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

US Patents and Regulatory Information for DANTRIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

Expired US Patents for DANTRIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982

International Patents for DANTRIUM

See the table below for patents covering DANTRIUM around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	116509
Israel	26182	1-((5-SUBSTITUTED)FURFURYLIDENE-AMINO)-HYDANTOINS AND IMIDAZOLIDINONES
Netherlands	147434
Norway	118068
United Kingdom	1097359

Dantrolene Sodium Market Dynamics and Financial Trajectory: A Comprehensive Overview

Market Overview of Dantrolene Sodium

Dantrolene sodium, marketed under the brand name DANTRIUM among others, is a specialized muscle relaxant medication primarily used in the management of malignant hyperthermia, neuroleptic malignant syndrome, and certain types of muscle spasticity. Here’s a detailed look at the market dynamics and financial trajectory of this critical drug.

Market Size and Growth Projections

The dantrolene sodium market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was approximately USD 1.2 billion, with projections indicating it will reach around USD 1.9 billion by 2033, representing a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2033[1].

Key Drivers of Market Growth

Increasing Prevalence of Malignant Hyperthermia

The rising incidence of malignant hyperthermia, a rare but potentially fatal condition triggered by certain anesthetic agents or muscle relaxants, is a primary driver of the market. The need for effective pharmacological interventions to manage this condition has solidified dantrolene sodium's position as a critical treatment[1].

Growing Awareness and Therapeutic Benefits

Growing awareness about the importance of prompt treatment for malignant hyperthermia and the recognition of dantrolene sodium's therapeutic benefits in managing other conditions such as neuroleptic malignant syndrome and muscle spasticity have also contributed to market growth[1].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in regions like North America and Europe, have enhanced the availability and accessibility of dantrolene sodium. This has been further augmented by the expansion of healthcare systems in the Asia-Pacific region[1].

Market Segmentation and Competitive Landscape

Dosage Forms and Applications

The market offers dantrolene sodium in various dosage forms, including oral capsules and injectable solutions, catering to diverse clinical needs. This versatility has helped in maintaining a strong market presence[1].

Key Market Players

The competitive landscape is characterized by the presence of both established pharmaceutical companies and generic drug manufacturers. Companies such as Olon Spa, ScinoPharm Taiwan, Ltd., Guangzhou Tosun Pharmaceutical, Elite Pharmaceuticals, and Biophore India Pharmaceuticals Pvt Ltd are among the leading players in this market[4].

Regional Analysis

North America and Europe

North America, particularly the United States, and Europe are leading markets for dantrolene sodium. These regions benefit from well-established healthcare infrastructures and robust reimbursement policies for specialized medications[1].

Asia-Pacific Region

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

Latin America and Middle East & Africa

While these regions present opportunities for growth, the availability and accessibility of dantrolene sodium may be relatively lower compared to other regions. However, they remain important markets for future expansion[1].

Financial Performance and Key Players

Eagle Pharmaceuticals: A Key Player

Eagle Pharmaceuticals, a significant player in the market, has seen notable financial performance related to dantrolene sodium. Their product, RYANODEX (dantrolene sodium), has been a key contributor to their revenue. In Q1 2020, RYANODEX sales were $11.4 million, up from $4.0 million in Q1 2019[3].

Revenue and Market Expansion

Eagle Pharmaceuticals' total revenue in 2021 was $171.5 million, with a strong cash position and diversified revenue streams. The company's strategic acquisitions, such as the acquisition of Acacia Pharma Group plc, have added products like BARHEMSYS and BYFAVO to their portfolio, further enhancing their market presence and financial outlook[2].

Research and Development

Exploring New Therapeutic Applications

Ongoing research and development efforts are crucial for the market's growth. For instance, Eagle Pharmaceuticals has been involved in various R&D initiatives, including the evaluation of RYANODEX for the treatment of COVID-19, traumatic brain injury, and Alzheimer’s disease. These efforts aim to expand the therapeutic applications of dantrolene sodium and improve its formulations[3].

Challenges and Restraints

Side Effects and Regulatory Landscape

Despite the growth, the market faces challenges such as the potential side effects associated with dantrolene sodium, including headache, nausea, drowsiness, and constipation. Additionally, the evolving regulatory landscape and the low incidence of malignant hyperthermia can pose restraints to market growth[1][4].

Future Outlook

Technological Advancements and Personalized Medicine

The future of the dantrolene sodium market is expected to be shaped by technological advancements in drug delivery systems and the increasing emphasis on personalized and patient-centric approaches to medical treatment. The integration of digital health solutions may also play a significant role in market expansion[1].

Market Predictions and Strategic Steps

The market is predicted to continue growing, driven by the persistent need for effective muscle relaxant therapies. Companies are expected to focus on developing improved formulations, exploring new therapeutic applications, and leveraging technological advancements to drive growth. Strategic acquisitions and collaborations will also be key in expanding market presence and revenue streams[1][4].

Key Takeaways

• The dantrolene sodium market is projected to grow from USD 1.2 billion in 2023 to USD 1.9 billion by 2033.
• The market is driven by the increasing prevalence of malignant hyperthermia and growing awareness about its treatment.
• North America and Europe are leading markets, with the Asia-Pacific region expected to experience the fastest growth.
• Key players include established pharmaceutical companies and generic drug manufacturers.
• Ongoing R&D efforts are crucial for expanding therapeutic applications and improving formulations.
• Challenges include side effects and the evolving regulatory landscape.

FAQs

What is the primary use of dantrolene sodium?

Dantrolene sodium is primarily used in the management of malignant hyperthermia, neuroleptic malignant syndrome, and certain types of muscle spasticity.

Which regions are leading the dantrolene sodium market?

North America, particularly the United States, and Europe are the leading markets, with the Asia-Pacific region expected to experience the fastest growth.

What are the key drivers of the dantrolene sodium market?

The key drivers include the increasing prevalence of malignant hyperthermia, growing awareness about its treatment, and advancements in healthcare infrastructure.

Who are some of the leading players in the dantrolene sodium market?

Leading players include Olon Spa, ScinoPharm Taiwan, Ltd., Guangzhou Tosun Pharmaceutical, Elite Pharmaceuticals, and Biophore India Pharmaceuticals Pvt Ltd.

What are the potential challenges facing the dantrolene sodium market?

Challenges include side effects associated with the drug, the evolving regulatory landscape, and the low incidence of malignant hyperthermia.

Sources

1. DataHorizzon Research: Dantrolene Sodium Market Size, Share, Growth, Statistics Report 2033.
2. Eagle Pharmaceuticals: Annual Report 2021.
3. Business Wire: Eagle Pharmaceuticals Reports First Quarter 2020 Results.
4. Allied Market Research: Dantrolene Sodium Market Size, Share and Forecast 2030.