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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate has ninety-one patent family members in twenty-six countries.

One supplier is listed for this compound.

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

International Patents:	91
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	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.

Recent Clinical Trials for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

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

Sponsor	Phase
Stanford University	PHASE2
Avadel	PHASE2

See all calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate clinical trials

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			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
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					Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes					Y

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2961399
China	111317730	γ羟基丁酸与单羧酸转运蛋白的施用 (Administration of gamma hydroxybutyrate with monocarboxylate transporters)
China	105025892	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Croatia	P20200215
China	105025892
Japan	2016503762

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	132019000000021	Italy		PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): 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
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721

Market Dynamics and Financial Trajectory for Oxybate-Based Pharmaceuticals

Last updated: July 30, 2025

Introduction

Oxybate derivatives—namely calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate—are central to treatments for specific neurological disorders, most notably narcolepsy with cataplexy. Their unique pharmacological profile, regulatory pathways, and market acceptance shape a complex landscape for investors, healthcare providers, and pharmaceutical companies. This analysis examines the current market dynamics, financial trajectories, and future outlook for these compounds, underpinning critical strategic decision-making.

Pharmacological Background and Therapeutic Indications

Sodium oxybate, the most extensively studied and commercially available form, is prescribed primarily for narcolepsy with cataplexy. It functions through GABA_B receptor modulation, promoting sleep stabilization and reducing cataplexy episodes. Other oxybate salts—calcium, magnesium, and potassium oxybate—are either investigational or less prominent in clinical practice. Their stability, bioavailability, and patentability influence their market potential.

Sodium oxybate is marketed as Xyrem in the United States, developed by Jazz Pharmaceuticals, which possesses exclusive rights and FDA approval since 2002. Its mechanism has garnered high efficacy; however, concerns over abuse potential and stringent scheduling (Schedule III) have impacted market expansion.

Market Dynamics

Regulatory and Patented Landscape

The regulatory environment is pivotal. Xyrem’s FDA approval solidified sodium oxybate's market presence. However, the FDA's rigorous scheduling reflects concerns over abuse, necessitating strict distribution controls—this poses logistical challenges and impacts revenue streams.

Patents for sodium oxybate have largely expired or are nearing expiry, opening pathways for generic competition. Jazz Pharmaceuticals maintains exclusivity through formulation patents and orphan drug status, but biosimilar entrants are anticipated, potentially eroding margins.

Other oxybate salts, such as calcium oxybate, lack FDA approval or proven efficacy, limiting their market penetration. Their development remains largely academic, with minimal commercial traction to date.

Market Size and Growth

The global narcolepsy treatment market was valued at approximately $1.2 billion in 2022 and is projected to grow at a CAGR of 7-9% through 2028, fueled by increased diagnosis rates and awareness. Sodium oxybate commands over 80% of this segment, driven by its proven efficacy.

Increased adoption is anticipated in the US and Europe, with emerging markets cautiously optimistic, contingent upon approval and healthcare infrastructure. Off-label use remains limited, given regulatory constraints and safety profiles.

Competitive Dynamics

Competitor drugs, such as modafinil and armodafinil, provide wakefulness promotion but do not address cataplexy directly, positioning oxybate therapies uniquely. Non-pharmacological approaches and patient preference shift the competitive landscape.

Novel therapies under investigation, such as dual orexin receptor antagonists and serotonin receptor modulators, threaten to phase out or supplement oxybate use. The entrance of generics and biosimilars could significantly reduce prices, pressuring profit margins.

Supply Chain and Distribution

Strict control of oxybate distribution through Risk Evaluation and Mitigation Strategies (REMS) programs limits supply flexibility. This constrains market expansion prospects but ensures safety and compliance, maintaining market stability for incumbent players.

Pricing and Reimbursement

Pricing strategies are influenced by high manufacturing costs and regulatory compliance expenses. Sodium oxybate commands premium pricing due to its efficacy, but affordability issues limit access in low-income regions. Reimbursement policies remain favorable in developed markets but vary globally, affecting overall market penetration.

Financial Trajectory

Revenue Projections

Estimates suggest the sodium oxybate market will sustain a compound annual growth rate (CAGR) of 7-9% over the next five years, bolstered by increasing diagnosis and adherence rates. However, the actual revenue might plateau or decline post-generic entry, which is anticipated within a 5-10 year horizon.

Cost Structure and Profitability

Research and development (R&D), manufacturing, regulatory compliance, and distribution logistics constitute significant expenses. As patents expire, profitability will hinge on competitive pricing and volume growth. The monopolistic position of current formulations ensures high margins; loss of exclusivity could erode this advantage substantially.

Investment Outlook

Pharmaceutical companies investing in novel oxybate formulations (e.g., extended-release or reformulated salts) could maintain revenue streams and extend patent life. Partnerships with biotech firms might facilitate the development of improved formulations, potentially capturing new or underserved patient segments.

Emerging Markets and Expansion

Entry into emerging markets is a lucrative but challenging avenue, requiring regulatory approvals and infrastructure investments. As healthcare systems mature, demand is expected to rise proportionally with awareness and diagnosis rates, providing near-term growth avenues.

Future Market Trends

• Biosimilar Competition: Anticipated to fragment the market, exerting downward pressure on prices.
• Innovative Delivery Systems: Development of alternative formulations (e.g., transdermal, injectable) may expand therapeutic options.
• Regulatory Evolution: Stricter regulations for abuse-deterrent formulations could influence product design and market access.
• Patient-centric Approaches: Growing emphasis on quality of life and personalized medicine could drive demand for tailored oxybate therapies.
• Therapeutic Innovation: Trials exploring oxybate derivatives for other indications (e.g., depression, substance use disorders) could create new markets.

Risks and Challenges

• Regulatory Hurdles: Delays or denials in approval for new formulations or salts.
• Generic Competition: Market erosion post-patent expiry, compelling companies to innovate.
• Abuse Potential: Regulatory restrictions might limit widespread adoption.
• Pricing Pressures: Payer restrictions and value-based reimbursement models threaten margins.
• Market Saturation: With widespread use, growth rates inherently slow.

Key Takeaways

• Sodium oxybate remains the dominant oxybate medication with a strong existing market, but face imminent patent expiration and biosimilar threats.
• Screening for novel formulations and delivery systems presents opportunities to prolong product lifecycle and secure revenue.
• Market expansion depends heavily on regulatory approvals, particularly in emerging markets, and reimbursement policies.
• Competitive landscape shifts could lead to price erosion, necessitating cost-effective manufacturing and innovative R&D investments.
• The overall market growth is promising but increasingly challenged by biosimilar entry and competitive innovation.

FAQs

1. What distinguishes sodium oxybate from other oxybate salts?
Sodium oxybate is the most studied and FDA-approved version, with established efficacy for narcolepsy. Its formulations are well-characterized, although other salts—calcium, magnesium, potassium—are under investigation but lack regulatory approval, limiting their clinical and commercial use.

2. How will patent expirations affect oxybate market dynamics?
Patent expirations for sodium oxybate may enable biosimilar and generic competition, reducing prices and squeezing profit margins. Companies must innovate through reformulations or expanded indications to sustain revenues.

3. Are there emerging therapies threatening oxybate formulations in narcolepsy?
Yes. Drugs like dual orexin receptor antagonists demonstrate potential as alternatives, but currently lack the efficacy profile for cataplexy, maintaining oxybate’s specific market niche.

4. What is the outlook for oxybate-related treatments in emerging markets?
Growth potential exists through regulatory approval and healthcare infrastructure development. However, challenges include affordability, supply chain logistics, and regional regulatory hurdles.

5. How might regulatory trends influence future oxybate formulations?
Increased regulation for abuse-deterrent features may drive innovation toward safer, reformulated products, influencing market offerings and compliance costs.

References

[1] Global Narcolepsy Treatment Market Report, 2022.
[2] FDA Drug Approvals Database.
[3] Jazz Pharmaceuticals Investor Presentations, 2022.
[4] Market Research Future, 2023.
[5] World Health Organization, 2022.