Wednesday, July 8, 2026
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Drug profile · INN

sodium oxybate

XYREM

sodium oxybate (XYREM) is a gaba-b receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N07) N07XX04
US status approved
Patents linked 16
Pipeline programs 14
News articles 0
Drug details — sodium oxybate
US status
approved
Class
Nervous system (N07)
Route
ORAL
Patents
16
Programs
14
Data quality
0.89
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Quick answer

sodium oxybate (XYREM) is a gaba-b receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sodium oxybate
Brand XYREM
Mechanism GABA-B receptor agonist
Target GABA-B receptor
Therapeutic class Nervous system (N07)
Route ORAL
Formulation FOR SUSPENSION, EXTENDED RELEASE
ATC code N07XX04
Originator Amneal Pharma Europe Ltd

Mechanism of action

GABA-B receptor agonist

Primary target: GABA-B receptor

Approval history

Authority Status Date
FDA approved —
EMA approved —

Pipeline programs

Search pipeline Sponsor programs
  1. Sodium Oxybate Phase 3 · Jazz Pharmaceuticals Ireland · Binge Eating Disorder
  2. Sodium Oxybate Phase 3 · Jazz Pharmaceuticals Ireland · Fibromyalgia
  3. Xyrem Phase 3 · Jazz Pharmaceuticals Ireland · Narcolepsy With Cataplexy
  4. Xyrem Phase 3 · Jazz Pharmaceuticals Ireland · Narcolepsy
  5. Xyrem (sodium oxybate) oral solution Phase 3 · Jazz Pharmaceuticals Ireland · Narcolepsy
  6. Xyrem® Phase 3 · Jazz Pharmaceuticals Ireland · Fibromyalgia
  7. Sodium Oxybate Phase 2 · Jazz Pharmaceuticals Ireland · Essential Tremor
  8. Sodium Oxybate Phase 2 · Jazz Pharmaceuticals Ireland · Alternating Hemiplegia of Childhood

Related & competitor drugs

Browse all drugs
  1. aripiprazole Nervous system (N05)
  2. baclofen GABA-B receptor agonist
  3. brexpiprazole Nervous system (N05)
  4. brivaracetam Nervous system (N03)
  5. bupivacaine Nervous system (N01)
  6. buprenorphine Nervous system (N07)

Related patents

Browse patents Amneal Pharma Europe Ltd patent hub

  1. US 12138233

    Methods of treating idiopathic hypersomnia

    Expires Mon Nov 07 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 11986446

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon May 16 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 11554102

    Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders

    Expires Mon Jan 12 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 11426373

    Gamma-hydroxybutyrate compositions and their use for the treatment of disorders

    Expires Mon Aug 25 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 11253494

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon Feb 17 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 10864181

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon Dec 10 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 10675258

    Method of using gamma-hydroxybutyrate compositions for the treatment of disorders

    Expires Mon Jun 04 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 10213400

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon Feb 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 10195168

    Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders

    Expires Mon Jan 31 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 9486426

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon Nov 03 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 9132107

    Gamma-hydroxybutyrate compositions and their use for the treatment of disorders

    Expires Mon Sep 10 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 9050302

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon Jun 04 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 8901173

    Gamma-hydroxybutyrate compositions and their use for the treatment of disorders

    Expires Mon Nov 27 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. US 8772306

    Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

    Expires Mon Jul 03 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. US 8771735

    Immediate release dosage forms of sodium oxybate

    Expires Mon Jul 03 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. US 8591922

    Gamma-hydroxybutyrate compositions and their use for the treatment of disorders

    Expires Mon Nov 21 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is sodium oxybate?

sodium oxybate (XYREM) is a gaba-b receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sodium oxybate?

XYREM is a marketed brand name for sodium oxybate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sodium oxybate?

sodium oxybate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.

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