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. There is one patent protecting this drug.

This drug has eight patent family members in five countries.

The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Twelve 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

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	3
Patent Applications:	2,922
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

RYANODEX is protected by one US patents.

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			Y

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

International Patents for RYANODEX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005013919
European Patent Office	1435781
Australia	2004262507
European Patent Office	1603513	COMPOSITIONS DE DANTROLÈNE (DANTROLENE COMPOSITIONS)
World Intellectual Property Organization (WIPO)	03000057

RYANODEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RYANODEX

Introduction to RYANODEX

RYANODEX (dantrolene sodium) is a novel formulation of the antidote for managing malignant hyperthermia (MH), a potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. Approved by the FDA in 2014, RYANODEX has revolutionized the treatment of MH with its rapid and efficient administration[1][4].

Market Need and Competitive Landscape

Malignant hyperthermia is a rare but life-threatening condition that requires immediate treatment. The traditional formulations of dantrolene sodium were cumbersome, requiring multiple vials and large volumes of sterile water, which could take up to 20 minutes to prepare and administer. RYANODEX, with its advanced nanosuspension technology, can be reconstituted and administered in less than one minute by a single healthcare practitioner, significantly improving response times and patient outcomes[1][4].

FDA Approval and Regulatory Status

RYANODEX was granted FDA approval in July 2014 and was also designated as an Orphan Drug, which may provide Eagle Pharmaceuticals with seven years of market exclusivity. This approval marked a significant milestone for Eagle Pharmaceuticals, as RYANODEX became the first product to be solely marketed by the company[1].

Financial Performance: Product Sales

Since its approval, RYANODEX has shown promising financial performance. In the first quarter of 2020, RYANODEX product sales were $11.4 million, a significant increase from $4.0 million in the first quarter of 2019. This growth was a key factor in the company's overall revenue, which was $46.0 million for Q1 2020[5].

In the fourth quarter of 2021, RYANODEX product sales were $6.1 million, although this represented a decline from the $10.2 million in Q4 2020. This decrease was part of a broader trend of lower product sales across several of Eagle Pharmaceuticals' products[2].

Revenue Trends

The revenue from RYANODEX has been a crucial component of Eagle Pharmaceuticals' overall financial health. Here are some key revenue trends:

• Quarterly Sales: In Q1 2020, RYANODEX sales contributed significantly to the company's total revenue of $46.0 million. However, by Q4 2021, the sales had decreased to $6.1 million, reflecting broader market and competitive dynamics[2][5].
• Annual Sales: The full-year 2021 saw a decline in RYANODEX sales by $3.0 million compared to the previous year, primarily due to volume decreases[3].

Gross Margin and Profitability

The introduction and sales of RYANODEX have positively impacted Eagle Pharmaceuticals' gross margin. In the first quarter of 2020, the gross margin was 83%, driven in part by the increase in RYANODEX product sales. However, the gross margin for 2021 was 75%, reflecting changes in revenue mix and product sales volumes[2][5].

Market Exclusivity and Patent Protection

RYANODEX benefits from Orphan Drug designation, which may provide seven years of market exclusivity. Additionally, Eagle Pharmaceuticals holds exclusive licenses for four U.S. patents related to RYANODEX, further protecting its market position[1].

Clinical and Market Impact

The rapid administration capability of RYANODEX has been hailed as a significant enhancement to MH treatment options. According to Henry Rosenberg, MD, CPE, and President of the Malignant Hyperthermia Association of the United States (MHAUS), "The ability for healthcare professionals to more quickly prepare and administer this new formulation of the antidote dantrolene sodium is expected to bring the crisis under control more rapidly and prevent severe complications from MH"[1].

Future Outlook and Growth Potential

Despite the recent decline in sales, RYANODEX remains a critical product in Eagle Pharmaceuticals' portfolio. The company's focus on organic growth and expanding its commercial portfolio, as seen with the launch of other products like PEMFEXY and the acquisition of Acacia Pharma Group, suggests a positive outlook for maintaining and potentially growing RYANODEX sales in the future[3].

Challenges and Competition

The pharmaceutical market is highly competitive, and Eagle Pharmaceuticals faces challenges from other products entering the market. For instance, the bendamustine market, where Eagle's other products like BENDEKA and BELRAPZO operate, saw increased competition in 2022. However, the unique formulation and rapid administration benefits of RYANODEX help it maintain a strong market position[2][3].

Key Takeaways

• Rapid Administration: RYANODEX can be reconstituted and administered in less than one minute, significantly improving response times for MH treatment.
• Market Exclusivity: Orphan Drug designation and exclusive patent licenses protect RYANODEX's market position.
• Financial Performance: RYANODEX has contributed significantly to Eagle Pharmaceuticals' revenue, although recent sales have declined.
• Clinical Impact: The product has been praised for its ability to quickly bring MH crises under control and prevent severe complications.
• Future Outlook: Despite current challenges, RYANODEX remains a vital part of Eagle Pharmaceuticals' portfolio with potential for future growth.

FAQs

Q: What is RYANODEX used for? A: RYANODEX (dantrolene sodium) is used for the treatment of malignant hyperthermia (MH), a potentially fatal disorder triggered by certain anesthesia agents.

Q: How quickly can RYANODEX be administered? A: RYANODEX can be reconstituted and administered in less than one minute by a single healthcare practitioner.

Q: What is the significance of RYANODEX's FDA approval? A: The FDA approval of RYANODEX marked the first significant enhancement to MH treatment options in over three decades and granted Eagle Pharmaceuticals potential seven-year market exclusivity.

Q: How has RYANODEX impacted Eagle Pharmaceuticals' financials? A: RYANODEX has been a key contributor to Eagle Pharmaceuticals' revenue, although recent sales have seen a decline.

Q: What are the competitive advantages of RYANODEX? A: RYANODEX benefits from its advanced nanosuspension technology, allowing for rapid reconstitution and administration, and is protected by Orphan Drug designation and exclusive patent licenses.

Cited Sources

1. FDA Approves Eagle Pharmaceuticals' Ryanodex® for the Treatment of Malignant Hyperthermia - Eagle Pharmaceuticals, Inc.
2. Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Results - GlobeNewswire
3. Annual Report 2022 - Eagle Pharmaceuticals, Inc. - Eagle Pharmaceuticals, Inc.
4. RYANODEX® (dantrolene sodium) | RYANODEX® for MH - RYANODEX.com
5. Eagle Pharmaceuticals Reports First Quarter 2020 Results - Business Wire