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Last Updated: March 16, 2025

SODIUM OXYBATE Drug Patent Profile


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

Sodium Oxybate is a drug marketed by Hikma and is included in one NDA.

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

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Drug patent expirations by year for SODIUM OXYBATE
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Recent Clinical Trials for SODIUM OXYBATE

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SponsorPhase
Mayo ClinicPhase 4
Centre Hospitalier Intercommunal de Toulon La Seyne sur MerPhase 4
Brigham and Women's HospitalEarly Phase 1

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Medical Subject Heading (MeSH) Categories for SODIUM OXYBATE
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma SODIUM OXYBATE sodium oxybate SOLUTION;ORAL 202090-001 Jan 17, 2017 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

EU/EMA Drug Approvals for SODIUM OXYBATE

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 2 of 2 entries

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

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