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
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	10,195,168		Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	11,426,373
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	9,050,302*PED				Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	8,591,922		Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	11,554,102		Y

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20220143852
Brazil	112022017900
Croatia	P20201685
European Patent Office	3335708	ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
European Patent Office	2961399
Canada	2902948

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	1990003-4	Sweden		PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
2957286	LUC00094	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0933372	13/2008	Austria		PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
3752510	CA 2025 00041	Denmark		PRODUCT NAME: VANZACAFTOR ELLER ET FARMACEUTISK ACCEPTABLELT SALT DERAF, FORTRINSVIS ET CALCIUM-SALT DERAF; REG. NO/DATE: EU/1/25/1943 20250701
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 Drugs

Last updated: February 20, 2026

What Are the Key Market Drivers for Calcium, Magnesium, Potassium, and Sodium Oxybate?

Oxybate drugs, including calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate, are primarily indicated for narcolepsy with cataplexy and alcohol use disorder. The market size is driven by clinical demand, regulatory approvals, and competitive landscape.

Clinical Demand

• Primary Indications: Narcolepsy, idiopathic hypersomnia, alcohol dependence.
• Prevalence: Narcolepsy impacts approximately 1 in 2,000 individuals globally; this has sustained demand for oxybate therapy.
• Treatment Gaps: Limited options without significant side effects sustain oxybate’s market position.

Regulatory Approval and Usage

• FDA Approvals:
  • Sodium oxybate (Xyrem): Approved since 2002.
  • Gamma-hydroxybutyrate (GHB) origin compound.
• Expanding Indications:
  • Recently, phase 3 trials explore oxybate in substance use disorders.
• Special Formulations:
  • New formulations and emerging salts (e.g., calcium oxybate) face approvals hurdles but could increase the addressable market.

Competitive Landscape

• Market Players:
  • Jazz Pharmaceuticals dominates with Xyrem.
  • Branded drugs face penetration barriers due to high costs and abuse potential.
• Generic Entry:
  • Pending or ongoing patent cliffs could lower prices from 2024 onward.

Market Challenges

• Abuse Potential:
  • Schedule III (US) classification limits wider adoption.
  • Illegal use in recreational settings impacts perception.
• Side Effects:
  • Nausea, dizziness, and sleep disturbance limit tolerability.
• Pricing:
  • High price points ($60,000–$70,000 annually) restrict access in healthcare systems.

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How Do Different Salt Forms Impact Market Dynamics?

Sodium Oxybate

• Market Share: Dominates due to historical approval and extensive clinical data.
• Formulation: Oral solution, powder.
• Challenges: Schedule III status, abuse potential.

Calcium, Magnesium, Potassium Oxybate

• Development Focus: Alternative salts aim to reduce abuse and improve tolerability.
• Research Status: Mostly in clinical trial phases, with no widespread approval.
• Potential Advantages: Lower abuse potential, better tolerability profiles.

Regulatory and Patenting Landscape

Salt Type	Approval Status	Patent Expiry	Market Penetration	Cost Implications
Sodium oxybate	Approved	2024 (patent cliff)	High	High
Calcium oxybate	Clinical	Pending	Low	Potentially lower
Magnesium oxybate	Preclinical	N/A	Very low	Unknown
Potassium oxybate	Preclinical	N/A	Very low	Unknown

What Is the Financial Trajectory?

Revenue Trends

• Historical Revenue: Jazz Pharmaceuticals reported over $700 million in 2022 sales of Xyrem.
• Growth Drivers: Increased diagnosis rates, expanding regulatory indications.
• Patent Cliff Impact:
  • US patent expiration scheduled for 2024.
  • Anticipated generic entry expected to pressure prices and margins.

Market Forecast

Year	Estimated Global Market Size	Compound Annual Growth Rate (CAGR)	Trends	Notes
2023	$1.2 billion	3.5%	Steady growth due to narcolepsy prevalence	Patent cliff imminent
2025	$1.4 billion	4.0%	Generics entering, price erosion	New formulations emerging

Cost and Pricing Dynamics

• Pricing Pressure: Falling from $60,000–$70,000/year toward $40,000–$50,000 as generics penetrate.
• Development Costs: High for new salts; clinical trials, regulatory filings, and patent protections require multi-year investments exceeding $100 million.

Future Income Sources

• Expanding indications like multiple sclerosis-related fatigue or alcohol dependence could extend revenue streams.
• Alternative salts could capture niche markets if regulatory hurdles are cleared, especially if abuse-reduction claims are substantiated.

What Are the Investment and R&D Implications?

1. Patent Expirations: Prepare for price competition post-2024, increasing importance of innovation and formulations.
2. Regulatory Pathways: Focus on clinical data supporting safety and abuse mitigations for novel salts.
3. Market Entry Barriers: Strict scheduling and abuse potential limit rapid adoption outside specialist centers.
4. Potential for Generics: Cost reductions may increase accessibility but pressure margins.

Key Takeaways

• The oxybate market is mature, with sodium oxybate leading due to early approval and extensive clinical use.
• Patent expirations and regulatory challenges challenge sustainability; generics are poised to reduce revenue permanently post-2024.
• Developing alternative salts like calcium oxybate may mitigate abuse and tolerability issues, creating new market opportunities.
• Market growth remains modest due to treatment limitations and regulatory constraints, with alternative indications or formulations offering future upside.
• Pricing pressures will intensify with generics, emphasizing the importance of pipeline innovation and new indications.

FAQs

1. What is the main driver for oxybate drug sales? A: Narcolepsy with cataplexy prevalence and lack of alternative treatments sustain demand.

2. When will generic versions of sodium oxybate enter the market? A: Patent expiry is scheduled for 2024, with generic entry likely shortly thereafter.

3. How do alternative salts like calcium oxybate differ from sodium oxybate? A: They aim to reduce abuse risk and improve tolerability; most still are in clinical development.

4. What are the regulatory hurdles for new oxybate salts? A: Demonstrating comparable efficacy and safety, gaining approval for reduced abuse potential, and navigating scheduling restrictions.

5. Will abuse potential limitations restrict market growth? A: Yes, scheduling status and recreational misuse reduce market penetration outside specialty settings.

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Citations

[1] U.S. Food and Drug Administration (FDA). (2002). Xyrem (sodium oxybate) approval announcement.
[2] Jazz Pharmaceuticals. (2022). Annual report.
[3] MarketWatch. (2022). Global oxybate market valuation and forecasts.
[4] U.S. Patent and Trademark Office. (2023). Patent expiration timelines for oxybate formulations.
[5] World Health Organization. (2021). Narcolepsy prevalence data.