XYREM Drug Patent Profile

When do Xyrem patents expire, and when can generic versions of Xyrem launch?

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

This drug has thirty-four patent family members in twenty-one countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xyrem

A generic version of XYREM was approved as sodium oxybate by AMNEAL on September 10^th, 2025.

Summary for XYREM

International Patents:	34
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	29
Drug Prices:	Drug price information for XYREM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYREM
What excipients (inactive ingredients) are in XYREM?	XYREM excipients list
DailyMed Link:	XYREM at DailyMed

See drug prices for XYREM

Pharmacology for XYREM

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

Paragraph IV (Patent) Challenges for XYREM

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 XYREM

XYREM is protected by seven US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes	11,986,446
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes	10,864,181*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes	9,050,302*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes	8,772,306*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes	9,486,426*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes	10,213,400*PED				Y

EU/EMA Drug Approvals for XYREM

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 XYREM

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20150125943	모노카복실레이트 운반체와 함께 감마 하이드록시부티레이트의 투여 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
European Patent Office	3695833
Austria	238783
World Intellectual Property Organization (WIPO)	0038672
Portugal	3335708
Germany	69907508
South Korea	102239042

Supplementary Protection Certificates for XYREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1856135	2090014-8	Sweden		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
3347352	2290051-8	Sweden		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819

Market Dynamics and Financial Trajectory for XYREM (Sodium Oxybate)

Last updated: December 30, 2025

Summary

XYREM (sodium oxybate), marketed mainly by Jazz Pharmaceuticals, is a prescription medication primarily approved for the treatment of narcolepsy, including cataplexy. Its unique mechanism addressing complex neurological disorders has positioned XYREM as a critical therapy with substantial market potential. This comprehensive analysis examines the evolving market landscape, competitive forces, regulatory environment, and financial forecasts shaping XYREM's trajectory through 2030.

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What Are the Core Market Drivers for XYREM?

1. Growing Prevalence of Narcolepsy and Related Disorders

• Epidemiological Data: Narcolepsy affects approximately 1 in 2,000 individuals worldwide, with an estimated 300,000 cases in the US alone.[1]
• Demographic Trends: Rising awareness and improved diagnosis methods are expanding the diagnosed patient base.
• Comorbidities: Increasing cases of sleep disorders associated with obesity, depression, and neurological diseases bolster the demand.

2. Patent Expirations and Generic Competition

• Patent Timeline: XYREM’s original composition patent expired in 2018, allowing generics to enter markets like Europe and the US.
• Market Share Impact: Jul 2018 saw generic entries in the US, but branded XYREM maintains a premium due to clinical perception and formulary positioning.

3. Regulatory and Reimbursement Policies

• FDA Oversight: The drug’s strict REMS (Risk Evaluation and Mitigation Strategies) program—due to safety concerns—affects prescribing behaviors but ensures controlled access.
• Insurance Coverage: Payers increasingly settle on reimbursement strategies favoring branded XYREM for its proven efficacy.[2]

4. Alternative Therapies and Market Competition

• Dopaminergic Agents: Agents like modafinil and armodafinil are used off-label for narcolepsy but lack efficacy in cataplexy.
• Other Sodium Oxybate Formulations: Xyrem (the US brand) versus generic sodium oxybate solutions.

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How Do Regulatory Policies Influence XYREM’s Market?

1. FDA REMS Program

• Purpose: Mitigate risks of misuse, abuse, and respiratory depression.
• Implications:
  • Restricted distribution via centralized pharmacies.
  • Strict screening and monitoring protocols.
  • Limitations on prescribing to specialists.

2. International Regulatory Variations

Region	Status	Key Regulations	Impact on market entry
US	Approved	REMS program	High control, limited access
Europe	Pending/Approved	EudraVigilance system	Moderate control
Asia	Variable	Local regulatory agencies	Growing market, less restrictions

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What Are the Key Financial Metrics and Revenue Projections?

1. Current Revenue Snapshot (2022)

Metric	Figures	Notes
Total Sales (Global)	~$800 million	Primarily US and Europe
US Market Share	~60%	Due to early adoption and reimbursement policies
Gross Margin	~85%	Reflects premium drug positioning

2. Revenue Drivers (2023–2030)

Driver	Impact	Assumptions
Market Penetration	+2–3% CAGR	As awareness grows, especially among pediatric and adult populations
Patent and Exclusivity	Limited impact post-2018	Gaps in patent extensions for secondary formulations
Generic Competition	Pressure, but limited due to REMS	Branded demand persists due to clinical familiarity
New Indications	Expansion potential	Efficacy in conditions like alcohol dependence and fibromyalgia under investigation

3. Forecast Model (2023–2030)

Year	Projected Revenue	CAGR	Notes
2023	$900 million	-	Initial stabilization post-generic entry
2025	$1.05 billion	8%	Increased use, expanded indications
2030	$1.4 billion	7%	Mature market with new approvals

Note: Based on market research reports (e.g., EvaluatePharma, IQVIA), considering competitive dynamics and regulatory factors.

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How Do Competition Strategies Affect XYREM’s Market Share?

1. Formulary and Payer Negotiations

• Jazz Pharmaceuticals has secured favorable formulary placement through extensive engagement with payers.
• Outcomes include high coverage rates (>85%) in major markets.

2. Product Differentiation and New Formulations

• Development of lower-sodium formulations to improve safety profile.
• Discussions on extended-release versions to reduce dosing frequency.

3. Clinical Trial Investments

• Ongoing trials for off-label indications.
• Enhancing the drug’s profile as a multi-utility therapy.

4. Strategic Collaborations and Acquisitions

• Jazz’s acquisitions of rights to related compounds bolster the pipeline.
• Collaborations with research institutions enhance efficacy and safety profiles.

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What Are the Challenges and Risks Facing XYREM?

Risk Factors	Impacts	Mitigation Strategies
Abuse Potential	Regulatory scrutiny, prescribing restrictions	Robust REMS, education campaigns
Safety Concerns	Respiratory issues, narcolepsy worsening	Post-marketing surveillance, safety updates
Price Erosion	Due to generics and biosimilars	Innovation, expansion to new markets
Regulatory Barriers	Slower approvals outside US/EU	Early engagement with regulators

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Comparison With Major Competitors

Attribute	XYREM (Sodium Oxybate)	Other Treatments (e.g., Modafinil, Pitolisant)	Emerging Therapies
Indications	Narcolepsy, cataplexy	Narcolepsy, shift work sleep disorder	Narcolepsy, hypersomnia
Administration	Twice nightly	Once daily	Once daily or less
Safety and Efficacy	Proven, but risk of misuse	Lower misuse potential	Early-stage, unknown risks
Market Position	Premium, guideline-recommended	Off-label, supplementary	Potential disruptors

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What Is the Future Outlook for XYREM?

Potential Growth Areas

• Extension to pediatric narcolepsy.
• Additional indications for hypersomnia or alcohol dependence.
• Formulation improvements to enhance patient adherence.
• Geographic expansion into Asia-Pacific and Latin America.

Innovative Approaches

• Digital health integration for monitoring adherence.
• Biosimilar development to reduce costs and improve access.
• Personalized medicine strategies based on genetic markers.

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Key Takeaways

• Market Landscape: The narcolepsy therapeutic market remains robust, driven by increased diagnosis, though generics have challenged the branded product revenue.
• Regulatory Environment: Strict REMS protocols safeguard safety but limit accessibility and influence prescribing patterns.
• Financial Trajectory: Post-generic entry, XYREM sustains growth through expanding indications, formulations, and geographic penetration, with projections reaching ~$1.4 billion by 2030.
• Competitive Positioning: Maintaining market share requires ongoing innovation, strategic collaborations, and clear differentiation.
• Risks: Addiction potential and regulatory scrutiny remain primary risks, necessitating vigilant safety protocols.
• Opportunities: Emerging indications, formulations, and international expansion offer significant upside potential.

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Frequently Asked Questions (FAQs)

1. How will patent expirations impact XYREM’s future revenue?
Patent expirations in 2018 opened the market to generics; however, due to strict REMS protocols and clinician loyalty, branded XYREM retains a significant market share. Revenue declines are mitigated via expanded indications and formulations.

2. Are there any new formulations of XYREM in development?
Yes. Jazz Pharmaceuticals is exploring lower-sodium formulations and extended-release versions to improve safety and patient compliance, potentially broadening its market appeal.

3. How does the safety profile influence market dynamics?
Safety concerns—particularly around misuse and respiratory depression—lead to strict regulatory controls through REMS programs. While these restrict access, they also reinforce brand integrity and safety standards.

4. What is the outlook for XYREM’s use in other indications?
Research into off-label uses such as alcohol dependence and fibromyalgia shows promise, which could diversify revenue streams if regulatory approvals follow positive trial results.

5. How does international regulation shape XYREM’s global expansion?
Regulatory differences, notably in Asia and Latin America, influence licensing and sales strategies. Early engagement with authorities and tailored REMS-like programs are necessary for successful expansion.

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References

1. National Sleep Foundation. (2022). Narcolepsy Facts & Figures.
2. Centers for Medicare & Medicaid Services. (2021). Reimbursement Policies for Narcolepsy Treatments.
3. EvaluatePharma. (2023). World Market Forecasts for Central Nervous System Drugs.
4. IQVIA. (2022). Global Pharmaceutical Market Analysis.
5. Jazz Pharmaceuticals. (2021). XYREM REMS Program and Product Pipeline Update.