Xyrem(oxybate)
Lumryz, Xyrem, Xywav (oxybate) is a small molecule pharmaceutical. Oxybate was first approved as Xyrem on 2002-07-17. It is used to treat cataplexy in the USA. It has been approved in Europe to treat cataplexy and narcolepsy.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Lumryz, Xyrem (discontinued: Oxybate)
CombinationsXywav
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sodium oxybate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUMRYZ | Avadel Pharmaceuticals | N-214755 RX | 2023-05-01 | 4 products, RLD |
| XYREM | Jazz Pharmaceuticals | N-021196 RX | 2002-07-17 | 1 products, RLD, RS |
Calcium oxybate
+
Magnesium oxybate
+
Potassium oxybate
+
Sodium oxybate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XYWAV | Jazz Pharmaceuticals | N-212690 RX | 2020-07-21 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lumryz | New Drug Application | 2023-06-07 |
| n/a | NDA authorized generic | 2022-10-04 |
| sodium oxybate | NDA authorized generic | 2023-04-25 |
| xyrem | New Drug Application | 2023-04-25 |
| xywav | New Drug Application | 2023-04-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cataplexy | HP_0002524 | D002385 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SODIUM OXYBATE, LUMRYZ, AVADEL CNS | |||
| 2030-05-01 | ODE-431 | ||
| 2026-05-01 | NP | ||
CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE, XYWAV, JAZZ | |||
| 2028-08-12 | ODE-369 | ||
| 2027-07-21 | ODE-361 | ||
| 2024-08-12 | I-870 | ||
| 2023-07-21 | NP | ||
SODIUM OXYBATE, XYREM, JAZZ PHARMS | |||
| 2026-04-26 | PED | ||
| 2025-10-26 | ODE-231 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Oxybate, Lumryz, Avadel Cns | |||
| 11583510 | 2042-02-07 | U-3578 | |
| 10925844 | 2040-02-28 | DP | |
| 10272062 | 2037-07-21 | DP | |
| 10736866 | 2037-07-21 | DP | |
| 10952986 | 2037-07-21 | U-3601 | |
| 10973795 | 2037-07-21 | DP | |
| 11000498 | 2037-07-21 | DP | U-3580 |
| 11052061 | 2037-07-21 | DP | |
| 11065224 | 2037-07-21 | DP | |
| 11400065 | 2037-07-21 | U-3579 | |
| 11504347 | 2037-07-21 | DP | |
| 11602512 | 2037-07-21 | U-3577 | |
| 11602513 | 2037-07-21 | U-3576 | |
| Calcium Oxybate / Magnesium Oxybate / Potassium Oxybate / Sodium Oxybate, Xywav, Jazz | |||
| 11426373 | 2037-09-19 | U-3432 | |
| 8772306 | 2033-03-15 | U-1532, U-3198 | |
| 9050302 | 2033-03-15 | U-1532 | |
| 9486426 | 2033-03-15 | U-1532 | |
| 10213400 | 2033-03-15 | U-2499 | |
| 10864181 | 2033-03-15 | U-1532, U-3017 | |
| 11253494 | 2033-03-15 | U-3323, U-3324 | |
| 8591922 | 2033-01-11 | DP | |
| 8901173 | 2033-01-11 | DP | |
| 9132107 | 2033-01-11 | DP | |
| 10195168 | 2033-01-11 | DP | |
| 10675258 | 2033-01-11 | U-2938 | |
| 11554102 | 2033-01-11 | DP | |
| Sodium Oxybate, Xyrem, Jazz Pharms | |||
| 7668730 | 2024-06-16 | U-1110 | |
ATC Codes
HCPCS
No data
Clinical
Clinical Trials
60 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Narcolepsy | D009290 | HP_0030050 | G47.4 | 3 | — | 8 | 4 | 3 | 18 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | 2 | 2 | 5 | 2 | — | 10 |
| Cataplexy | D002385 | HP_0002524 | — | 1 | — | 4 | 1 | — | 6 |
| Sleepiness | D000077260 | — | R40.0 | 1 | 1 | 3 | 1 | — | 6 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | 1 | 2 | 2 | — | 4 |
| Syndrome | D013577 | — | — | — | — | — | 4 | — | 4 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | 1 | — | 3 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 3 | — | 3 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | 3 | — | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 4 | — | — | 5 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 4 | — | — | 5 |
| Tremor | D014202 | HP_0001337 | R25.1 | — | 3 | 1 | — | — | 3 |
| Dysphonia | D055154 | — | R49.0 | — | 2 | 1 | — | — | 2 |
| Hoarseness | D006685 | HP_0001609 | R49.0 | — | 2 | 1 | — | — | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | 1 | — | — | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | — | 1 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | 1 | — | — | 1 |
| Bulimia | D002032 | — | F50.2 | — | 1 | 1 | — | — | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 3 | — | — | — | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | 1 | 2 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 1 | — | — | 1 | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | 1 | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | — | 1 | 2 |
| Hemiplegia | D006429 | HP_0011099 | G81.0 | 1 | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| Ventilator weaning | D015300 | — | — | — | 1 | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
| Dyssomnias | D020920 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Hiv | D006678 | — | — | 1 | — | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | — | 1 |
| Intrinsic sleep disorders | D020919 | — | F51.03 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Psychological trauma | D000067073 | — | — | — | — | — | — | 1 | 1 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 1 | 1 |
| Physiological stress | D013312 | — | — | — | — | — | — | 1 | 1 |
| Sleep deprivation | D012892 | — | F51.12 | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | — | 1 | 1 |
| Hernia | D006547 | HP_0100790 | K40-K46 | — | — | — | — | 1 | 1 |
| Incisional hernia | D000069290 | HP_0004872 | K43.2 | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Oxybate |
| INN | — |
| Description | 4-hydroxybutyric acid is a 4-hydroxy monocarboxylic acid that is butyric acid in which one of the hydrogens at position 4 is replaced by a hydroxy group. It has a role as a general anaesthetic, a GHB receptor agonist, a sedative and a neurotoxin. It is a 4-hydroxy monocarboxylic acid and a hydroxybutyric acid. It is functionally related to a butyric acid. It is a conjugate base of a 4-hydroxybutyrate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCCO |
Identifiers
| PDB | — |
| CAS-ID | 591-81-1 |
| RxCUI | 1546380 |
| ChEMBL ID | CHEMBL1342 |
| ChEBI ID | 30830 |
| PubChem CID | 10413 |
| DrugBank | DB01440 |
| UNII ID | — |
Target
No data
Variants
No data
Financial
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Oxybate – Jazz Pharmaceuticals
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Xywav – Jazz Pharmaceuticals
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Xyrem – Jazz Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,402 documents
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Safety
Black-box Warning
Black-box warning for: Lumryz, N/a, Sodium oxybate, Xyrem, Xywav
Adverse Events
Top Adverse Reactions
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68,198 adverse events reported
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