Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate - Generic Drug Details

What are the generic drug sources for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate and what is the scope of freedom to operate?

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate is the generic ingredient in one branded drug marketed by Jazz and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate has seventy-eight patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

International Patents:	78
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate
DailyMed Link:	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

Constraining patent/regulatory exclusivity:

THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS

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 calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

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

Anatomical Therapeutic Chemical (ATC) Classes for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

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 calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

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	8,901,173		Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	10,864,181*PED				Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	11,986,446
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	8,772,306*PED				Y

International Patents for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

Country	Patent Number	Title	Estimated Expiration
China	105025892	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Portugal	2931268
European Patent Office	2961399	ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
European Patent Office	3799867
World Intellectual Property Organization (WIPO)	2014093791

Supplementary Protection Certificates for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
2957286	2018C/047	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2365988	2018C/006	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Calcium, Magnesium, Potassium, and Sodium Oxybate

Introduction to Oxybate Therapies

Oxybate therapies, including calcium, magnesium, potassium, and sodium oxybate, are increasingly prominent in the treatment of sleep disorders, particularly narcolepsy and idiopathic hypersomnia. Here, we delve into the market dynamics and financial trajectory of these medications.

Market Growth Drivers

Increasing Recognition of Narcolepsy

The market for oxybate therapies is driven by the growing recognition and diagnosis of narcolepsy. As healthcare awareness and diagnosis rates rise, especially in underdiagnosed regions, new opportunities for market penetration emerge[1].

Investment in Sleep Disorder Research

Heightened investment in sleep disorder research has significantly contributed to the growth of the oxybate market. This research has led to better understanding and treatment options for narcolepsy and other sleep disorders[1].

Regulatory Support

FDA approvals and supportive regulatory frameworks play a crucial role in market expansion. For instance, the approval of Xywav, a low-sodium oxybate, has opened up new avenues for treatment with reduced sodium content, addressing concerns related to high sodium intake[3][4].

Market Restraints

Stringent Regulatory Frameworks

Despite the growth, the market faces challenges due to stringent regulatory frameworks governing the distribution and prescription of oxybate therapies. These regulations are in place due to the potential for misuse and dependence[1].

Generic Competition and Patent Expirations

The impact of patent expirations and generic competition can alter market dynamics. Generic versions of sodium oxybate can reduce the market share of brand-name products, affecting revenue streams[1].

High Costs and Limited Access

High treatment costs and limited patient access in developing regions pose significant barriers to market growth. These costs can be prohibitive, even with the presence of favorable reimbursement policies[1][5].

Financial Performance

Revenue Growth

The financial performance of oxybate therapies has been robust. For example, Xywav, a low-sodium oxybate, saw net product sales increase by 39% to $326.6 million in the second quarter of 2023 compared to the same period in 2022. Jazz Pharmaceuticals anticipates its oxybate franchise to reach $2 billion in revenue by 2025[2].

Market Share

Sodium oxybate dominates the narcolepsy therapeutics market, with a revenue share of 46.70% in 2022. This segment is expected to grow at the fastest CAGR over the forecast period, driven by high prescription rates and favorable reimbursement policies[5].

Regional Market Dynamics

North America

North America dominates the narcolepsy therapeutics market, with a revenue share of 38.03% in 2022. The region's strong R&D activities, result-oriented collaborations, and government initiatives fuel market growth[5].

Product Innovations

Low-Sodium Oxybate: Xywav

Xywav, a mixture of calcium, magnesium, potassium, and sodium oxybate, is a significant innovation. It offers a 92% reduction in sodium content compared to traditional sodium oxybate (Xyrem), making it a safer option with reduced chronic sodium burden[3][4].

Ready-to-Drink Solutions

Innovative delivery systems, such as ready-to-drink solutions, can capture new consumer bases and improve patient adherence. These formulations enhance the convenience and ease of use, potentially boosting market penetration[1].

Clinical and Safety Concerns

Sodium Content

The high sodium content in traditional sodium oxybate (Xyrem) has been a significant concern, equating to 109% of the American Heart Association's daily ideal sodium intake for most adults. Xywav addresses this issue with its significantly reduced sodium content[3].

Risk Management Plans

Regulatory bodies have implemented Risk Management Plans (RMPs) to ensure the safe use of oxybate therapies. These plans are crucial in mitigating clinical and safety concerns associated with these medications[4].

Market Opportunities

Personalized Medicine

A personalized medicine approach can tailor oxybate treatments to individual patient needs, potentially boosting patient outcomes and sales. This tailored approach can enhance treatment efficacy and patient satisfaction[1].

Expanded Indications

The role of sodium oxybate in treating cataplexy can be expanded to improve patient quality of life. Xywav, for instance, is approved for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy and for idiopathic hypersomnia in adults[3].

Challenges and Mitigation Strategies

Patient Adherence and Proper Usage

Addressing concerns on patient adherence and proper usage is crucial. Educational efforts, patient assistance programs, and innovative delivery systems can help mitigate these challenges[1].

Cost Barriers

Expansions in insurance coverage and patient assistance programs can help mitigate the high costs associated with oxybate therapies. These initiatives can improve access to these medications, especially in developing regions[1][5].

Key Takeaways

• The oxybate market is driven by increasing recognition of narcolepsy and investment in sleep disorder research.
• Regulatory approvals, particularly for low-sodium oxybate options like Xywav, are key to market growth.
• High costs and limited access in developing regions are significant challenges.
• Innovations in delivery systems and personalized medicine approaches offer potential for market expansion.
• Financial performance is robust, with anticipated revenue growth to $2 billion by 2025 for the oxybate franchise.

FAQs

1. What is the primary driver of the oxybate market growth?

The primary driver is the increasing recognition and diagnosis of narcolepsy, coupled with heightened investment in sleep disorder research.

2. What is the significance of Xywav in the oxybate market?

Xywav is a low-sodium oxybate approved for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy and for idiopathic hypersomnia in adults, offering a 92% reduction in sodium content compared to traditional sodium oxybate.

3. How does the high sodium content in traditional sodium oxybate impact patient health?

The high sodium content in traditional sodium oxybate (Xyrem) equates to 109% of the American Heart Association's daily ideal sodium intake for most adults, posing significant health risks.

4. What are the main challenges facing the oxybate market?

The main challenges include stringent regulatory frameworks, generic competition, high treatment costs, and limited patient access in developing regions.

5. How are manufacturers addressing the cost barriers associated with oxybate therapies?

Manufacturers are addressing cost barriers through expansions in insurance coverage and patient assistance programs to improve access to these medications.

Cited Sources:

1. 360iResearch: Sodium Oxybate Oral Medications Market Size 2025-2030.
2. BioSpace: Jazz Pharmaceuticals Announces Second Quarter 2023 Financial Results and Raises 2023 Full-Year Financial Guidance.
3. PR Newswire: Jazz Pharmaceuticals Presents Data Highlighting the Continued Need for Low-Sodium Treatment Option Xywav.
4. Health Canada: Regulatory Decision Summary for Xywav.
5. Grand View Research: Narcolepsy Therapeutics Market Size & Share Report, 2030.