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Last Updated: December 22, 2024

SODIUM OXYBATE - Generic Drug Details


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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, Hikma, and Jazz Pharms, and is included in three NDAs. There are thirty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium oxybate has sixty-three 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.

Drug Prices for SODIUM OXYBATE

See drug prices for SODIUM OXYBATE

Recent Clinical Trials for SODIUM OXYBATE

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

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

See all SODIUM OXYBATE clinical trials

Generic filers with tentative approvals for SODIUM OXYBATE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe500MG/MLSOLUTION;ORAL
⤷  Subscribe⤷  Subscribe500MG/MLSOLUTION;ORAL

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

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

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SODIUM OXYBATE

Country Patent Number Title Estimated Expiration
China 109789096 ⤷  Subscribe
European Patent Office 3335708 ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) ⤷  Subscribe
Uruguay 37341 FORMULACIONES DE GAMMA-HIDROXIBUTIRATO DE LIBERACIÓN MODIFICADA CON FARMACOCINÉTICA MEJORADA ⤷  Subscribe
Japan 2024069489 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) ⤷  Subscribe
Japan 7553453 ⤷  Subscribe
Hong Kong 1256965 γ羥基丁酸與單羧酸轉運蛋白的施用 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) ⤷  Subscribe
European Patent Office 2961399 ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SODIUM OXYBATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203431 CA 2015 00014 Denmark ⤷  Subscribe PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2465580 SPC/GB21/030 United Kingdom ⤷  Subscribe 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
0579826 SPC/GB02/042 United Kingdom ⤷  Subscribe PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
0145340 99C0005 Belgium ⤷  Subscribe PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431 92666 Luxembourg ⤷  Subscribe PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431 15C0013 France ⤷  Subscribe PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2932970 18C1043 France ⤷  Subscribe PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

SODIUM OXYBATE Market Analysis and Financial Projection Experimental

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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