DANTRIUM Drug Patent Profile

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

Dantrium is a drug marketed by Ph Health and is included in two NDAs.

The generic ingredient in DANTRIUM is dantrolene sodium. There are five drug master file entries for this compound. Fourteen 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:	4
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	2
Patent Applications:	59
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
University of Massachusetts, Worcester	Phase 1/Phase 2
American Heart Association	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
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Ph Health	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for DANTRIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	3,415,821
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	3,415,821
Ph Health	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	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
Sweden	303758
Belgium	686434
France	1550961

Market Dynamics and Financial Trajectory for DANTRIUM (Dantrolene)

Last updated: February 10, 2026

Overview of DANTRIUM Market Position

Dantrolene, marketed as DANTRIUM, is an oral and injectable medication primarily used to treat malignant hyperthermia—a rare but life-threatening reaction to anesthesia—and spasticity associated with conditions such as multiple sclerosis and cerebral palsy. The drug’s sales are driven by its clinical applications, regulatory status, manufacturing considerations, and competition from alternative treatments.

Market Size and Growth Drivers

The global market for dantrolene derivatives, including DANTRIUM, was estimated at $150 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of approximately 3% over the next five years, reaching around $175 million by 2027. This modest growth is primarily fueled by increased diagnosis and awareness of spasticity conditions, expanding use beyond malignant hyperthermia, and geographic expansion into emerging markets.

Key Factors Impacting Market Dynamics

• Clinical Demand: Increasing burden of neurodegenerative and neuromuscular disorders drives demand for spasticity treatments. The rise in identified malignant hyperthermia cases enhances the need for DANTRIUM in perioperative settings.
• Regulatory Environment: DANTRIUM’s approval status remains stable in major markets. The FDA approved it for malignant hyperthermia in 1979, with ongoing monitoring. Regulatory policies on drug safety influence manufacturing and marketing.
• Manufacturing Capacity: Limited production facilities restrict supply, creating potential bottlenecks during peak demand. Efforts to expand manufacturing are ongoing but face regulatory and technical hurdles.
• Competitive Landscape: Alternatives such as baclofen, tizanidine, and botulinum toxins are used for spasticity management. For malignant hyperthermia, dantrolene remains the only FDA-approved drug, providing a competitive edge in that niche.

Pricing and Reimbursement Trends

Pricing strategies differ by market. In the US, DANTRIUM’s average wholesale price (AWP) for a 100 mg capsule ranges from $4.50 to $6.50. Injectable formulations in hospitals can exceed $150 per vial. Insurance reimbursements and hospital budgets influence utilization rates. Reimbursement changes or formulary restrictions could impact sales volumes.

Regulatory and Patent Key Dates

• 1979: FDA approves DANTRIUM for malignant hyperthermia.
• 2000: Extended approval for spasticity in multiple sclerosis and cerebral palsy.
• 2018: Generic versions enter select markets, exerting downward pressure on prices.
• 2020-2023: Ongoing discussions on manufacturing standards due to quality concerns in some suppliers.

Financial Trajectory Insights

Sales revenue for DANTRIUM has seen stability due to its niche applications, with slight declines in some markets attributable to generic competition and manufacturing challenges. The drug’s RMB (revenue market share) in its core indications is estimated at 70%–80%. Sales are projected to remain flat or grow modestly at a CAGR of approximately 2–3% until 2027, as new indications or formulations have yet to be developed and approved.

Note: The absence of novel formulations or significant pipeline developments limits rapid growth prospects. Future growth depends heavily on market expansion and manufacturing improvements.

Emerging Opportunities and Risks

• Opportunities: Development of new formulations, combination therapies, or expanded indications (e.g., neuroprotective effects in stroke recovery).
• Risks: Regulatory delays, supply chain disruptions, competitive market from novel agents, and off-label use of alternatives.

Summary Table of Market and Financial Metrics

Metric	2022	2027 (Projected)	Comments
Market size	$150 million	$175 million	3% CAGR
Sales revenue	~$130 million	~$150 million	Stable, with slight growth expected
Price per unit	$4.50–$6.50 (capsules)	Slight variation	Pricing pressures from generics
Manufacturing capacity	Limited, with expansion ongoing	Stable but constrained	Supply chain considerations
Market share (core indications)	70–80%	Stable	Dominant in malignant hyperthermia niche

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Key Takeaways

• Market size remains modest but stable, driven by niche applications.
• Growth prospects are limited by patent expirations, generic competition, and manufacturing constraints.
• Pricing is under pressure in some markets, affecting margins.
• Future opportunities hinge on new formulations and expanded indications.
• Risks include regulatory delays, supply bottlenecks, and competitive threats from newer therapies.

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FAQs

1. What factors could drive growth for DANTRIUM in the next five years?
Expansion into new indications, geographic markets (particularly emerging markets), and improvements in manufacturing capacity could facilitate growth.

2. How does generic competition affect DANTRIUM’s revenue?
Generic versions reduce pricing power and market share, pressuring profit margins but not eliminating demand entirely due to its unique approval for malignant hyperthermia.

3. Are there any recent regulatory changes impacting DANTRIUM?
No significant recent regulatory changes, but ongoing quality control and manufacturing standards influence supply and costs.

4. What are the primary competitors to DANTRIUM?
For spasticity, baclofen, tizanidine, and botulinum toxin competitors exist. For malignant hyperthermia, DANTRIUM holds a regulatory monopoly.

5. What potential developments could alter the drug’s financial trajectory?
New formulations, additional indications, or pipeline products could boost revenue, while supply disruptions or increased competition could stall growth.

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References:

1. IQVIA, Market Data, 2022.
2. FDA Database, Drug Approvals and Labeling, 1979–2023.
3. Company filings and estimates, 2023.
4. Healthcare Cost and Utilization Project (HCUP), 2022.
5. Industry reports and market analyses, 2023.