SODIUM OXYBATE - Generic Drug Details

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

Sodium oxybate is the generic ingredient in three branded drugs marketed by Avadel Cns, Amneal, Ascent Pharms Inc, Hikma, and Jazz Pharms, and is included in five NDAs. There are thirty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium oxybate has sixty-eight patent family members in twenty-three countries.

There are five drug master file entries for sodium oxybate. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for SODIUM OXYBATE

International Patents:	68
US Patents:	38
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	56
Patent Applications:	2,147
Drug Prices:	Drug price trends for SODIUM OXYBATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SODIUM OXYBATE
What excipients (inactive ingredients) are in SODIUM OXYBATE?	SODIUM OXYBATE excipients list
DailyMed Link:	SODIUM OXYBATE at DailyMed

See drug prices for SODIUM OXYBATE

Recent Clinical Trials for SODIUM OXYBATE

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

Sponsor	Phase
Kristina Simonyan	PHASE1
Stanford University	PHASE4
Avadel	PHASE2

See all SODIUM OXYBATE clinical trials

Generic filers with tentative approvals for SODIUM OXYBATE

Applicant	Application No.	Strength	Dosage Form
		500MG/ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SODIUM OXYBATE

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

Medical Subject Heading (MeSH) Categories for SODIUM OXYBATE

Adjuvants, Anesthesia

Anesthetics, Intravenous

Anatomical Therapeutic Chemical (ATC) Classes for 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 SODIUM OXYBATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XYREM	Oral Solution	sodium oxybate	500 mg/mL	021196	1	2010-07-08

US Patents and Regulatory Information for SODIUM OXYBATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No			Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No			Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-001	May 1, 2023		RX	Yes	Yes			Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No

EU/EMA Drug Approvals for SODIUM OXYBATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma Ltd	Xyrem	sodium oxybate	EMEA/H/C/000593Treatment of narcolepsy with cataplexy in adult patients.	Authorised	no	no	no	2005-10-13
D&A Pharma	Hopveus	sodium oxybate	EMEA/H/C/004962Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.	Refused	no	no	no		2020-07-06

International Patents for SODIUM OXYBATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1215539	γ羥基丁酸與單羧酸轉運蛋白的施用 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
Australia	2017300845	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
World Intellectual Property Organization (WIPO)	2020178695
Slovenia	3335708
Spain	2659284
Poland	2961399

Supplementary Protection Certificates for SODIUM OXYBATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
2666774	SPC/GB20/031	United Kingdom		PRODUCT NAME: RELEBACTAM OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT.; REGISTERED: UK EU/1/19/1420 (NI) 20200217; UK PLGB 53095/0053 20200217

Market Dynamics and Financial Trajectory for Sodium Oxybate

Last updated: July 27, 2025

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Introduction

Sodium oxybate, also known as gamma-hydroxybutyrate (GHB), is a central nervous system depressant used predominantly for managing narcolepsy and alcohol dependence. Its unique pharmacological profile, regulatory status, and evolving market landscape shape its commercial potential and financial trajectory. As an essential therapeutic agent, sodium oxybate's market dynamics are influenced by regulatory oversight, patent statuses, competitive alternatives, and emerging clinical applications.

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Pharmacological Profile and Therapeutic Applications

Sodium oxybate's primary indication is for narcolepsy with cataplexy, a debilitating sleep disorder characterized by excessive daytime sleepiness and loss of muscle tone (cataplexy). The drug's efficacy in improving sleep architecture and reducing cataplexy episodes has established it as a cornerstone treatment, notably marketed under the brand Xyrem by Jazz Pharmaceuticals.

Recent clinical investigations explore sodium oxybate's potential in treating alcohol use disorder, restless legs syndrome, and opioid withdrawal, potentially broadening its therapeutic scope. However, regulatory approvals for these off-label or investigational uses remain pending or limited, constraining immediate market expansion.

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Regulatory Environment and Market Access

Sodium oxybate enjoys controlled substance status due to its narrow therapeutic window and abuse potential, classified as Schedule III in the United States and Schedule IV in many jurisdictions. The U.S. Food and Drug Administration (FDA) approved Xyrem in 2002, affirming its safety and efficacy profile within strict prescribing and dispensing protocols.

In regions like Europe and Asia, regulatory approval is variable. The European Medicines Agency (EMA) approved sodium oxybate for narcolepsy, but regulatory hurdles and stringent scheduling impact broader market access. These restrictions influence supply chains, reimbursement policies, and ultimately, the drug's financial outlook.

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Market Landscape and Competitive Dynamics

The global narcolepsy therapeutics market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 12-15% over the next five years, driven by increased diagnosis rates and awareness. The market share of sodium oxybate remains dominant due to its proven efficacy, although competition from stimulants (modafinil, armodafinil) and emerging agents could impact sales.

Key competitors:

• Stimulants: Modafinil (Provigil), armodafinil (Nuvigil)
• Other wake-promoting agents: Solriamfetol, pitolisant
• Investigational drugs: Orexin receptor agonists and other novel sleep disorder therapies

Despite this competitive landscape, sodium oxybate's unique mechanism—restoring normal sleep patterns and reducing cataplexy—proffers a therapeutic advantage that sustained demand capitalizes on.

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Market Challenges and Opportunities

Challenges:

• Regulatory Stringency: The Schedule III/Schedule IV classification hampers wider distribution and commercialization. Stringent prescribing controls elevate administrative costs and limit patient accessibility.
• Abuse Potential and Safety Profile: The risk of misuse necessitates surveillance, impacting prescribing habits and patient acceptance.
• Pricing and Reimbursement: High treatment costs, compounded by regulatory controls, impede reimbursement frameworks in certain regions.

Opportunities:

• Novel Formulations: Development of extended-release formulations or non-controlled substance variants could expand market access.
• Expanding Indications: Clinical evidence supporting additional uses like alcohol dependence or sleep apnea offers avenues for growth.
• Market Expansion in Emerging Regions: Countries with nascent sleep disorder markets represent growth opportunities, contingent on regulatory adaptations.

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Financial Trajectory and Revenue Forecast

In 2022, Xyrem generated approximately $1.2 billion in global revenue for Jazz Pharmaceuticals, reflecting stable demand within its approved indication. The long-term revenue prospects hinge on several factors:

1. Market Penetration: Continued uptake in existing markets sustained by increasing diagnosis and awareness.
2. Pipeline Development: Potential approval of formulations with less regulatory scrutiny or broader indications.
3. Pricing Strategies: Premium pricing justified by clinical benefits, balanced against reimbursement challenges.

Analyst estimates project a compound annual growth rate (CAGR) of 4-6% over the next five years for sodium oxybate sales, assuming stable regulatory landscapes and minimal competitive erosion. However, achieving this trajectory relies on navigating regulatory hurdles, addressing safety concerns, and expanding clinical uses.

Key financial considerations include:

• Supply Chain and Manufacturing Costs: High-quality production adhering to stringent regulatory standards impacts margins.
• Patent Life and Exclusivity: Patent expiry timelines influence the timing of generics and biosimilars, pressuring prices and revenues.
• Market Expansion Initiatives: Investment in clinical research and regional approvals can contribute to revenue growth.

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Future Outlook and Strategic Implications

The future market trajectory for sodium oxybate hinges on regulatory evolution, clinical expansion, and innovation in drug delivery systems. Strategic partnerships with regional regulators, investments in formulation technology, and clinical trials for expanded indications can reinforce its market position.

Moreover, the rising burden of sleep disorders globally and increased recognition of narcolepsy underscore the sustained importance of sodium oxybate. However, competition from alternative wake-promoting agents necessitates continuous differentiation through safety, efficacy, and patient adherence advantages.

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Key Takeaways

• Market Stability: Sodium oxybate maintains a significant share in narcolepsy management, with stable revenues driven by proven efficacy and patient adherence.
• Regulatory Impact: Stringent scheduling limits market expansion; innovations in formulation and use cases are critical to overcoming these barriers.
• Competitive Dynamics: While faced with competition from stimulants and emerging agents, sodium oxybate's unique mechanism sustains its therapeutic niche.
• Growth Opportunities: Broader indications, regional market entry, and novel formulations present pathways for expansion.
• Financial Outlook: Long-term revenue depends on regulatory navigation, patent management, and clinical development efforts, with projected growth modest but steady.

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FAQs

1. What factors influence the pricing of sodium oxybate?
Pricing is driven by manufacturing costs, regulatory compliance, market demand, and reimbursement models. Its controlled status and high treatment efficacy justify premium pricing, but reimbursement policies can limit patient access.

2. How does regulatory classification impact sodium oxybate's market?
Being classified as a controlled substance necessitates strict prescribing and distribution controls, increasing regulatory burdens and limiting market expansion compared to less regulated drugs.

3. Are there any new developments that could alter sodium oxybate's market trajectory?
Yes, ongoing clinical research exploring expanded indications, new formulations (e.g., extended-release), and potential biosimilar entries could significantly influence its market positioning and revenues.

4. What are competitive threats to sodium oxybate in narcolepsy therapy?
Stimulants such as modafinil and armodafinil, as well as emerging wake-promoting agents like solriamfetol, challenge sodium oxybate's market share, especially with more flexible dosing and fewer safety concerns.

5. Can sodium oxybate's therapeutic scope expand beyond narcolepsy?
Clinical trials are evaluating its use for alcohol dependence, restless legs syndrome, and other sleep disorders. Successful approval could diversify revenue streams and bolster market growth.

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References

[1] Jazz Pharmaceuticals. (2022). Xyrem (sodium oxybate) prescribing information.
[2] MarketsandMarkets. (2023). Sleep disorder therapeutics market analysis.
[3] U.S. FDA. (2002). Approval of Xyrem for narcolepsy.
[4] European Medicines Agency. (2021). Sodium oxybate approval overview.
[5] ClinicalTrials.gov. (2023). Ongoing studies on sodium oxybate expansion.