Sodium oxybate - Generic Drug Details

What are the generic drug sources for sodium oxybate and what is the scope of patent protection?

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

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

There are five drug master file entries for sodium oxybate. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for sodium oxybate

International Patents:	66
US Patents:	37
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	50
Patent Applications:	1,964
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
Mayo Clinic	Phase 4
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Phase 4
Brigham and Women's Hospital	Early Phase 1

See all sodium oxybate clinical trials

Generic filers with tentative approvals for SODIUM OXYBATE

Applicant	Application No.	Strength	Dosage Form
		500MG/ML	SOLUTION;ORAL
		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	214755-004	May 1, 2023		RX	Yes	No	12,109,186		Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No	12,138,239		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	214755-002	May 1, 2023		RX	Yes	No	12,097,175		Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-001	May 1, 2023		RX	Yes	Yes	11,000,498		Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No	11,602,513

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/000593 Treatment of narcolepsy with cataplexy in adult patients.	Authorised	no	no	no	2005-10-13
D&A Pharma	Hopveus	sodium oxybate	EMEA/H/C/004962 Substitution 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
Canada	2902948	ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOIQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
Japan	2020100670	薬物動態が改善された放出調節ガンマ−ヒドロキシ酪酸塩製剤 (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS)
Canada	3127871	COMPOSITIONS DE GAMMA-HYDROXYBUTYRATE PRESENTANT UNE PHARMACOCINETIQUE AMELIOREE A L'ETAT ALIMENTE (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE)
Canada	2902948
European Patent Office	3487483	FORMULATIONS À LIBÉRATION MODIFIÉE DE GAMMA-HYDROXYBUTYRATE AYANT UNE PHARMACOCINÉTIQUE AMÉLIORÉE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS)
Israel	240874	מתן של גמא -הידרוקסיבוטיראט עם נשאי מונוקרבוקסילאט (Administration of gamma hydroxybutyrate with monocarboxylate transporters)

Supplementary Protection Certificates for sodium oxybate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
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
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401

Market Dynamics and Financial Trajectory of Sodium Oxybate

Market Overview

Sodium oxybate, a medication primarily used to treat narcolepsy and cataplexy, is experiencing significant growth in the pharmaceutical market. Here are the key dynamics and financial trends shaping this market.

Market Size and Growth

The sodium oxybate market was valued at USD 2.3 billion in 2023 and is projected to reach USD 4.8 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.1% from 2024 to 2031[1].

Drivers of Market Growth

Increasing Awareness and Diagnostics

The market expansion is largely driven by rising awareness of narcolepsy and improvements in diagnostic technologies, leading to more patient diagnoses and increased access to treatment[1][4].

Research and Development

Sustained research and development spending is driving innovation in novel formulations and potential new uses for sodium oxybate. This includes exploring its application in other central nervous system disorders, which could broaden the market[1][4].

Regulatory Environment

Favorable regulatory frameworks and expanding healthcare access in emerging nations are also contributing to the market's growth. Regulatory approvals and supportive frameworks play a crucial role in the market's expansion[1][4].

Economic and Demographic Factors

The Asia-Pacific region is expected to grow at the quickest rate, driven by strong economic growth, increased public awareness, rising disposable income, and significant investments in the biotechnology and pharmaceutical industries[3].

Market Segmentation

By Application

The market is segmented into various applications, including oral solutions, capsules, tablets, and extended-release formulations. The primary use is in treating narcolepsy and cataplexy, with a significant market share contributed by the sodium oxybate division[1][4].

By Product

The narcolepsy therapeutics market, which includes sodium oxybate, is segmented into narcolepsy with cataplexy, narcolepsy without cataplexy, and secondary narcolepsy. Sodium oxybate holds a substantial share, particularly in treating narcolepsy with cataplexy[3].

Geographical Regions

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America currently holds the largest market share, but the Asia-Pacific region is expected to grow rapidly[1][3].

Financial Performance

Revenue and Royalties

Jazz Pharmaceuticals, a key player in the sodium oxybate market, reported significant financial growth. Royalties from high-sodium oxybate authorized generics (AGs) increased to $58.2 million in the third quarter of 2024, up from $28.9 million in the same period in 2023[2][5].

Total Oxybate Revenue

Total oxybate revenue, including royalties from AGs, is annualizing at $1.9 billion. This indicates a robust financial trajectory for sodium oxybate, driven by strong demand and expanding market reach[5].

Challenges and Restraints

Regulatory and Safety Concerns

Stringent regulatory frameworks governing the distribution and prescription of sodium oxybate due to its potential for misuse and dependence pose significant challenges. Clinical and safety concerns also affect its acceptance in the market[4].

High Costs and Limited Access

High costs associated with treatment and limited patient access in developing regions are additional barriers to market growth. However, insurance coverage expansions and patient assistance programs can help mitigate these cost barriers[4].

Innovation and Opportunities

Novel Formulations and Delivery Methods

There are vast opportunities in researching novel formulations or delivery methods to improve patient compliance and safety. Innovations such as ready-to-drink solutions can capture new consumer bases and enhance market penetration[4].

Expanding Therapeutic Uses

Expanding the application of sodium oxybate to other central nervous system disorders through clinical studies can further broaden the market. Personalized medicine approaches can also tailor treatments to boost patient outcomes and sales[4].

Competitive Landscape

The market is characterized by high entry barriers due to regulatory requirements and competitive dynamics influenced by generic entries alongside branded drugs. Market share analysis provides insights into the performance and challenges faced by vendors, helping them devise effective strategies to gain a competitive edge[4].

Key Takeaways

• The sodium oxybate market is expected to grow significantly, driven by increasing awareness of narcolepsy and improvements in diagnostic technologies.
• Favorable regulatory frameworks and expanding healthcare access in emerging nations are key drivers.
• The market faces challenges such as stringent regulatory frameworks, high costs, and limited access in developing regions.
• Innovation in novel formulations and expanding therapeutic uses offer significant growth opportunities.
• The financial trajectory is robust, with total oxybate revenue annualizing at $1.9 billion.

FAQs

1. What is the projected market size of sodium oxybate by 2031?

The sodium oxybate market is expected to reach USD 4.8 billion by 2031[1].

2. What are the primary drivers of the sodium oxybate market growth?

The primary drivers include increasing awareness and diagnostics of narcolepsy, sustained R&D spending, and favorable regulatory environments[1][4].

3. Which region is expected to grow the fastest in the sodium oxybate market?

The Asia-Pacific region is expected to grow at the quickest rate due to strong economic growth and increased public awareness[3].

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

The main challenges include stringent regulatory frameworks, high costs, limited patient access in developing regions, and clinical and safety concerns[4].

5. How is innovation impacting the sodium oxybate market?

Innovation in novel formulations, delivery methods, and expanding therapeutic uses is expected to drive market growth and improve patient outcomes[4].

Cited Sources:

1. Market Research Intellect - Sodium Oxybate Market Size, Share and Forecast to 2031
2. PR Newswire - Jazz Pharmaceuticals Announces Third Quarter 2024 Financial Results
3. BioSpace - Narcolepsy Therapeutics Market Size to Surpass USD 6.90 Billion by 2032
4. 360iResearch - Sodium Oxybate Oral Medications Market Size 2025-2030
5. BioSpace - Jazz Pharmaceuticals Announces Third Quarter 2023 Financial Results and Updates Financial Guidance

Last updated: 2024-12-16