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. Thirteen 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:	3
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	2
Patent Applications:	67
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	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	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	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	AB	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	3,415,821
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	3,415,821
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	3,415,821
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	3,415,821

International Patents for DANTRIUM

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

Country	Patent Number	Title	Estimated Expiration
Belgium	686434
Israel	26182	1-((5-SUBSTITUTED)FURFURYLIDENE-AMINO)-HYDANTOINS AND IMIDAZOLIDINONES
Switzerland	483446	Verfahren zur Herstellung von 1-((5-substituierten)-Furfurylidenamino)-hydantoinen und -imidazolidinonen
France	1550961
Sweden	303758

Market Dynamics and Financial Trajectory for DANTRIUM (Dantrolene)

Last updated: July 29, 2025

Introduction

Dantrolene, marketed commercially as DANTRIUM, is a skeletal muscle relaxant primarily used to treat malignant hyperthermia (MH) and neuroleptic malignant syndrome (NMS). Since its original approval in the 1970s, DANTRIUM has established a niche market, but evolving healthcare landscape, regulatory changes, and emerging therapeutic alternatives influence its market dynamics and financial outlook. This report provides an in-depth analysis of the current market environment, regulatory factors, competitive landscape, and future financial trajectory for DANTRIUM.

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Market Overview

Therapeutic Indications and Demand Drivers

DANTRIUM's primary indication, malignant hyperthermia, is a rare but life-threatening pharmacogenetic disorder triggered by certain anesthetics. The prevalence is estimated at 1 in 5,000 to 1 in 50,000 anesthesia administrations worldwide, emphasizing the niche but critical role of DANTRIUM in perioperative care [1].

Secondary uses include treatment of neuroleptic malignant syndrome and off-label management of conditions like spasms related to spinal cord injury or cerebral palsy, though these are less prominent in the drug's core market. The demand for DANTRIUM remains largely driven by:

• Anesthesia practices: The need for immediate availability in surgical settings.
• Regulatory mandates: Hospitals and clinics mandated to stock MH crisis management drugs.
• Healthcare infrastructure: The ability to maintain stockpiles influences procurement patterns.

Market Size Estimation

Global sales of DANTRIUM are estimated to be in the range of $50-$100 million annually, predominantly generated from North America and Europe [2]. Although the drug's specialty status limits its volume, its essential role in anesthesia emergencies sustains steady demand.

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Competitive Landscape & Market Dynamics

Existing Market Players

DANTRIUM's primary manufacturer is FDA-approved, with similar products available from generic manufacturers [3]. The market is characterized by:

• Limited competition: Due to the critical nature and storage requirements, new entrants face barriers.
• Generic prevalence: Most sales stem from generic formulations, inhibiting significant R&D investment for newer versions.
• Supply chain considerations: Manufacturing complexity and regulatory compliance influence availability.

Emerging Therapeutic Alternatives

Recent developments in pharmacogenetics and alternative crisis management approaches are impacting DANTRIUM's dominance. Notably:

• Alternative drugs: Dantrolene's therapy is nearly exclusive; however, research into novel agents minimizing side effects and manufacturing complexities continues.
• Genetic screening: Improved identification of susceptible individuals may reduce acute MH episodes, thereby impacting demand.

Regulatory and Reimbursement Factors

Regulatory bodies mandating stocking for anesthesia clinics, coupled with hospital protocols, sustain demand. Nonetheless, reimbursement policies and stockpile requirements influence procurement budgets and frequency.

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Market Challenges and Opportunities

Challenges

• Limited market expansion: The niche status and rarity of MH restrict growth potential.
• Manufacturing constraints: Dantrolene’s complex production process, involving stability issues, impacts supply consistency and inflates costs [4].
• Regulatory hurdles: Stringent storage, handling, and distribution regulations for a critical emergency drug pose logistical challenges.

Opportunities

• Global outreach: Expanding markets in emerging economies with increasing anesthesia procedures may offer growth.
• Orphan drug designation: Advocacy for MH as an orphan condition can grant benefits such as market exclusivity.
• Formulation innovation: Development of ready-to-use formulations or shorter infusion times could improve usability, boosting demand.

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Financial Trajectory and Future Outlook

Historical Financial Performance

DANTRIUM has exhibited stable, if modest, revenue streams, with manufacturer profitability supported by high-margin generics. The high cost structure for manufacturing and regulatory compliance moderately impact margins but are mitigated by steady demand.

Forecasted Market Trends

Based on epidemiological data, technological advancements, and healthcare investment trends, the financial outlook for DANTRIUM appears to be:

• Stable in mature markets: Given consistent demand for emergency stock.
• Slow growth potential: Limited by the rarity of approved indications.
• Potential downturn risks: Emergence of alternative therapies and improved preventive strategies could reduce emergency cases over time.

Impact of COVID-19

Pandemic disruptions temporarily affected global supply chains and elective surgeries, reducing procedural volumes and, in turn, some demand. However, as healthcare systems normalize, demand is expected to rebound.

Long-term Outlook

Optimistically, steady global hospital protocols and regulatory requirements will sustain DHTRIUM’s place in anesthesia crisis preparedness. Conversely, significant innovations in treatment protocols or preventive approaches could challenge its relevance, leading to plateaus or modest declines.

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Regulatory & Patent Considerations

While dantrolene patents have expired, secondary patents related to formulations or delivery systems might influence market exclusivity temporarily. Continuous regulatory evaluations emphasize safety and supply, affecting manufacturing and distribution.

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Key Takeaways

• DANTRIUM maintains a stable, niche market driven by the critical need in anesthesia emergencies.
• Market growth is constrained by the rarity of indications and high manufacturing complexities.
• Supply chain robustness and regulatory compliance are strategic priorities for manufacturers.
• Emerging practices and preventive strategies, including genetic screening, could gradually diminish demand.
• Focused efforts on formulation improvements and expanding geographic reach can secure future revenues.

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FAQs

1. What is the primary therapeutic use of DANTRIUM?
DANTRIUM (dantrolene) is mainly used to treat malignant hyperthermia, a rare genetic disorder triggered during anesthesia, and neuroleptic malignant syndrome.

2. How significant is the global market for DANTRIUM?
The estimated global annual sales range between $50 million and $100 million, with North America and Europe being the predominant markets.

3. What factors influence demand for DANTRIUM?
Demand is driven by anesthesia procedure volume, hospital protocols mandating MH treatment preparedness, and supply chain reliability.

4. Are there emerging therapies threatening DANTRIUM’s market position?
Currently, no direct substitutes threaten its core indication. However, advancements in genetic screening and preventive measures could reduce emergency cases over time.

5. What strategic opportunities exist for manufacturers of DANTRIUM?
Expanding into emerging markets, optimizing formulations, and leveraging orphan drug status for regulatory incentives offer growth avenues.

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References

[1] Larach, M. G., et al. (2010). Malignant hyperthermia: update on diagnosis and management. Anesthesiology, 113(3), 482–492.
[2] IQVIA data; Market Research Reports on Specialty Pharmaceuticals.
[3] FDA Drug Label for DANTRIUM (Dantrolene).
[4] Rosenberg, H., et al. (2015). Dantrolene: A historical perspective. Anesthesia & Analgesia, 124(4), 1207–1214.