XYWAV Drug Patent Profile

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

Xywav is a drug marketed by Jazz and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in twenty-six countries.

The generic ingredient in XYWAV is calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xywav

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 12, 2028. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XYWAV

International Patents:	90
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for XYWAV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYWAV
What excipients (inactive ingredients) are in XYWAV?	XYWAV excipients list
DailyMed Link:	XYWAV at DailyMed

See drug prices for XYWAV

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XYWAV

Constraining patent/regulatory exclusivity:

THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS

NDA:

212690

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for XYWAV

Drug Class	Central Nervous System Depressant
Physiological Effect	Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Paragraph IV (Patent) Challenges for XYWAV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XYWAV	Oral Solution	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	0.234 g/0.096 g/ 013 g/0.04 g per mL	212690	1	2021-04-12

US Patents and Regulatory Information for XYWAV

XYWAV is protected by sixteen US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes			Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes					Y

International Patents for XYWAV

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013359114	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
China	105025892
European Patent Office	3695833
Mexico	2015007531
Norway	3027826

Supplementary Protection Certificates for XYWAV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2365988	122018000012	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	2018C/047	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	LUC00094	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321

Market Dynamics and Financial Trajectory for Xywav

Introduction

Xywav, a low-sodium oxybate formulation developed by Jazz Pharmaceuticals, has been a significant driver of the company's revenue growth, particularly in the sleep medicine segment. Here, we delve into the market dynamics and financial trajectory of Xywav, highlighting its performance, patient growth, and future prospects.

Approval and Indications

Xywav is approved by the FDA to treat cataplexy and/or excessive daytime sleepiness in narcolepsy and idiopathic hypersomnia (IH), making it the only therapy specifically approved for IH[2][4].

Market Performance

Revenue Growth

In 2023, Xywav's net product sales surged by 33% to $1.273 billion, and in the fourth quarter of 2023, sales increased by 20% to $337 million compared to the same periods in 2022. This growth is a testament to the drug's increasing adoption and market penetration[2][5].

Patient Growth

The number of active patients on Xywav has consistently increased. As of the fourth quarter of 2023, there were approximately 12,300 active patients, with 9,525 patients with narcolepsy and 2,775 patients with idiopathic hypersomnia. By the second quarter of 2024, this number had risen to about 13,225 active patients, including 9,925 narcolepsy patients and 3,300 IH patients[1][4].

Key Drivers of Growth

Lower Sodium Content

One of the primary reasons for the switch to Xywav is its lower sodium content compared to traditional oxybate formulations like Xyrem. The real-world TENOR study published in Sleep Medicine highlighted that the most common reason for switching to Xywav was the long-term health benefits associated with its lower sodium content[1][2].

Clinical Evidence

A review of scientific evidence published in Neurology and Therapy showed that oxybate regimens, including Xywav, provide substantial and highly similar medical benefits on subjective and objective measures of sleep and daytime function, regardless of dosing. This robust clinical evidence supports the continued adoption of Xywav[1].

Financial Highlights

Total Sleep Revenue

The total sleep revenue for Jazz Pharmaceuticals, which includes Xywav, branded Xyrem, and high-sodium authorized generic royalty revenues, exceeded $1.9 billion in 2023. This figure underscores the dominance of Xywav in the sleep medicine market[1].

Royalties from Authorized Generics

Royalties from high-sodium oxybate authorized generics were $75.9 million in 2023 and $39.4 million in the fourth quarter of 2023. Jazz Pharmaceuticals expects these royalties to exceed $200 million in 2024, reflecting increased fixed-rate royalty structures in the authorized generic agreements[1][5].

Competitive Landscape

Xyrem Sales Decline

The sales of Xyrem, the high-sodium oxybate formulation, have been declining significantly. In 2023, Xyrem net product sales decreased by 44% to $569.7 million, and in the fourth quarter of 2023, they decreased by 57% to $106.7 million. This decline is largely due to the shift towards Xywav, which offers a lower sodium alternative[1][5].

Future Developments

Clinical Trials

Jazz Pharmaceuticals is planning to initiate a phase 1b trial of JZP441 for type 1 narcolepsy patients in the second half of 2024. This trial aims to further understand orexin agonism and inform future development efforts, potentially expanding the company's sleep medicine portfolio[4].

Market Guidance

For 2024, Jazz Pharmaceuticals expects continued growth in Xywav sales, driven by its strong market position and increasing patient base. The company has raised its total revenue guidance, with expectations of over $4 billion, underpinned by the growth of Xywav, Epidiolex, and Rylaze, as well as royalties from authorized generics[5].

Expert Insights

"Jazz’s record revenues of over $1 billion in the second quarter were driven by strong execution and increased demand for our key growth drivers, Xywav, Epidiolex, and Rylaze," said Bruce Cozadd, Chairman and Chief Executive Officer of Jazz Pharmaceuticals. This statement reflects the company's confidence in Xywav's market performance and its role as a key growth driver[4].

Key Takeaways

• Revenue Growth: Xywav's net product sales increased by 33% to $1.273 billion in 2023.
• Patient Growth: The number of active Xywav patients has consistently increased, reaching approximately 13,225 by the second quarter of 2024.
• Lower Sodium Content: The primary reason for switching to Xywav is its lower sodium content, offering long-term health benefits.
• Clinical Evidence: Robust clinical evidence supports the medical benefits of Xywav.
• Financial Performance: Total sleep revenue exceeded $1.9 billion in 2023, with royalties from authorized generics expected to exceed $200 million in 2024.
• Future Developments: A phase 1b trial of JZP441 is planned for the second half of 2024 to explore orexin agonism.

FAQs

What is Xywav used for?

Xywav is used to treat cataplexy and/or excessive daytime sleepiness in narcolepsy and idiopathic hypersomnia (IH).

How has Xywav's revenue performed in recent years?

Xywav's net product sales increased by 33% to $1.273 billion in 2023 and by 13% in the second quarter of 2024 compared to the same periods in the previous year.

Why are patients switching to Xywav from other oxybate formulations?

The most common reason for switching to Xywav is the long-term health benefits associated with its lower sodium content.

What is the current patient base for Xywav?

As of the second quarter of 2024, there were approximately 13,225 active Xywav patients, including 9,925 narcolepsy patients and 3,300 IH patients.

What future clinical trials is Jazz Pharmaceuticals planning for its sleep medicine portfolio?

Jazz Pharmaceuticals is planning to initiate a phase 1b trial of JZP441 for type 1 narcolepsy patients in the second half of 2024 to further understand orexin agonism.

Sources

1. Sleep Review Magazine: "Xywav Drives Jazz Pharmaceuticals' Sleep Revenue"
2. PR Newswire: "Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results and Provides 2024 Financial Guidance"
3. Jazz Pharmaceuticals Investor Relations: "Jazz Pharmaceuticals Announces Second Quarter 2023 Financial Results"
4. Sleep Review Magazine: "Xywav Helps Propel Jazz to Over $1 Billion in Q2 Revenues"
5. Jazz Pharmaceuticals Investor Relations: "Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results"