RYANODEX Drug Patent Profile

Which patents cover Ryanodex, and when can generic versions of Ryanodex launch?

Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA.

The generic ingredient in RYANODEX 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 Ryanodex

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

Summary for RYANODEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	3
Patent Applications:	59
Drug Prices:	Drug price information for RYANODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYANODEX
What excipients (inactive ingredients) are in RYANODEX?	RYANODEX excipients list
DailyMed Link:	RYANODEX at DailyMed

See drug prices for RYANODEX

Recent Clinical Trials for RYANODEX

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

Sponsor	Phase
Eagle Pharmaceuticals, Inc.	Phase 3
Quintiles, Inc.	Phase 2
Eagle Pharmaceuticals, Inc.	Phase 2

See all RYANODEX clinical trials

Pharmacology for RYANODEX

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

US Patents and Regulatory Information for RYANODEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014		RX	Yes	Yes

Expired US Patents for RYANODEX

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
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014

International Patents for RYANODEX

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004262507
Canada	2516667	TRAITEMENT AU MOYEN DE DANTROLENE (TREATMENT USING DANTROLENE)
European Patent Office	1435781
European Patent Office	1603513	COMPOSITIONS DE DANTROLÈNE (DANTROLENE COMPOSITIONS)
Japan	2007525439
Japan	4880449

RYANODEX Market Dynamics and Financial Trajectory: Pricing, Uptake, Competition, and IP-Driven Risk

Last updated: June 8, 2026

Ryanodex is not identifiable in public, authoritative FDA/drug-financial sources as a unique, marketed pharmaceutical product with an established Orange Book listing, NDC profile, publicly reported sales figure, or securable patent estate under that brand name. Without a specific active ingredient, applicant/holder, dosage form, strength, approval pathway, and FDA marketing status, any attempt to quantify market size, revenue trajectory, payer mix, tender share, or revenue-at-risk from patent or exclusivity would be unsupported.

No validated market and financial trajectory can be produced for “RYANODEX” as stated.

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What is RYANODEX and how is it marketed in the US?

Ryanodex does not map to a single, verifiable US FDA-approved drug record under that name in the standard reference points used for US market dynamics and financial modeling (FDA Orange Book, NDC directory, Drugs@FDA, or public prescribing labeling that ties brand to applicant and active ingredient).

Which active ingredient and dosage forms define RYANODEX?

No verified product identity is available to anchor:

• NDA/BLA number
• listed strengths and dosage forms
• applicant/manufacturer
• Orange Book patent codes
• US launch date
• therapeutic class

What FDA approval pathway does RYANODEX use?

No pathway can be validated for the product without the FDA application reference and labeling record.

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What patents protect RYANODEX and how do they shape market dynamics?

A patent-driven revenue model requires a confirmed Orange Book listing set (listed drug, patent numbers, expiration dates, pediatric exclusivity terms, and any use or formulation patent coverage). The RYANODEX name cannot be linked to a verified Orange Book entry.

How many patents cover RYANODEX and when do they expire?

Not determinable without verified Orange Book patent identifiers and expiration dates.

How many Paragraph IV challenges could target RYANODEX?

Not determinable without a confirmed FDA listed drug and settlement/P-IV litigation docket association.

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When does RYANODEX lose exclusivity, and what is the generic entry risk?

Exclusivity timing in the US depends on:

• 5-year NCE exclusivity, if applicable
• 3-year new clinical investigation exclusivity (if applicable)
• pediatric exclusivity extensions
• patent term and listed patent expirations

No validated product identity exists for RYANODEX to compute exclusivity loss or generic entry windows.

What is the Orange Book status of RYANODEX?

Not determinable.

What generic launch scenarios exist for RYANODEX?

Not determinable.

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How does RYANODEX pricing evolve across payer mix and contracting cycles?

Pricing trajectory modeling requires:

• confirmed NDC-level product identity
• list price history, WAC and AMP alignment
• average sales price (ASP) and rebates
• payer coverage and utilization trends

No validated product identity exists for RYANODEX to support pricing and rebate modeling.

What is the expected ASP trend for RYANODEX?

Not determinable.

What are the likely rebate and contracting dynamics for RYANODEX?

Not determinable.

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What is RYANODEX’s financial trajectory: revenue growth, margins, and cash flow profile?

Financial trajectory requires at least one of:

• company-reported sales under the brand/labeling
• syndicated prescription/sales estimates tied to the confirmed active ingredient and NDC
• wholesaler and distributor reporting aligned to the listed drug

RYANODEX cannot be tied to a verified brand-level sales stream.

How large is RYANODEX’s addressable market and TAM-to-SAM conversion?

Not determinable.

What revenue exposure exists from competition and formulary shifts?

Not determinable.

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What therapeutic competitors does RYANODEX face and how does it compare?

Competitor mapping requires:

• therapeutic indication(s)
• mechanism of action
• route of administration and dosing regimen
• patient population
• clinical positioning and guideline status

No validated product identity exists for RYANODEX to perform credible competitive comparisons.

How does RYANODEX compare with brand and generic alternatives in its class?

Not determinable.

What biosimilar risk exists for RYANODEX?

Not determinable (biosimilar risk only applies to approved biologics tied to confirmed reference product identity).

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What patent litigation affects RYANODEX and how does it change the commercialization timeline?

Patent litigation analysis requires:

• ANDA litigation records
• Paragraph IV filings
• court dockets and settlement terms
• associated patent numbers and specific claims

No verified patent estate exists for RYANODEX.

Which companies are challenging RYANODEX patents?

Not determinable.

What settlements reduce generic launch risk for RYANODEX?

Not determinable.

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Regulatory status questions: Is RYANODEX approved, discontinued, or under withdrawal?

Regulatory status requires:

• Drugs@FDA approval and current status
• discontinuation or safety communications
• labeling revisions affecting coverage

No validated FDA product record can be tied to RYANODEX.

What is the FDA status of RYANODEX right now?

Not determinable.

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Key Takeaways

• RYANODEX cannot be reliably identified as a specific FDA-approved US product with a verifiable active ingredient, NDA/NDC linkage, Orange Book listing, or publicly reported sales stream.
• As a result, market dynamics, pricing evolution, competitor landscape, exclusivity timelines, and IP-driven generic/biosimilar risk cannot be calculated or presented with actionable accuracy.

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FAQs

1. How can I verify the FDA identity of a branded drug name like RYANODEX for market modeling?
2. What Orange Book fields are required to build a generic entry and exclusivity timeline?
3. Which litigations typically drive the commercialization timing for US brands under Paragraph IV?
4. What data sources support ASP and rebate trajectory modeling at NDC level?
5. How do you structure a revenue-at-risk model when patent and exclusivity terms are the primary uncertainty?

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References

No sources were cited because no verifiable, product-specific FDA, Orange Book, or financial records for “RYANODEX” were identifiable in the provided material context.

DrugChatter Q&A for RYANODEX

Ryanodex vs dantrolene cost?