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  1. pharmadog
  2. ›drugs
  3. ›Xywav
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(calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate)

Marketedupdated 3mo ago
by $JAZZ Jazz Pharmaceuticals plc
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval2 co-mentions · 1 sources
  • drugSODIUM OXYBATE1 co-mentions · 1 sources
  • tagSmall Molecule1 co-mentions · 1 sources
  • drugsodium oxybate ER1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 11 investigational indications.

all catalysts(1)

approval · 1
Nov 5, 2025
approval
9mo ago
SODIUM OXYBATE — FDA approval
(calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate)
→

Trials studying (calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate)

  • phase2Extended-release Sodium Oxybate in Childrenrecruitingn=36
  • phase4A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsycompletedn=207

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 21, 2027
340 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (155)

  • Mar 16, 2042method-of-use (U-3705)US 11779557
  • Mar 16, 2042method-of-use (U-3705)US 11779557
  • Mar 16, 2042method-of-use (U-3705)US 11779557
  • Mar 16, 2042method-of-use (U-3705)US 11779557
  • Feb 7, 2042method-of-use (U-3578)US 11583510
  • Feb 7, 2042method-of-use (U-3578)US 11583510
  • Feb 7, 2042method-of-use (U-3578)US 11583510
  • Feb 7, 2042method-of-use (U-3578)US 11583510
  • Feb 22, 2041method-of-use (U-4044)US 12138233
  • Feb 28, 2040formulationUS 10925844
  • Feb 28, 2040formulationUS 10925844
  • Feb 28, 2040formulationUS 10925844
  • Feb 28, 2040formulationUS 10925844
  • Sep 19, 2037method-of-use (U-3432)US 11426373
  • Jul 21, 2037formulationUS 10272062
  • Jul 21, 2037formulationUS 10272062
  • Jul 21, 2037formulationUS 10272062
  • Jul 21, 2037formulationUS 10272062
  • Jul 21, 2037formulationUS 10736866
  • Jul 21, 2037formulationUS 10736866
  • Jul 21, 2037formulationUS 10736866
  • Jul 21, 2037formulationUS 10736866
  • Jul 21, 2037method-of-use (U-3601)US 10952986
  • Jul 21, 2037method-of-use (U-3601)US 10952986
  • Jul 21, 2037method-of-use (U-3601)US 10952986
  • Jul 21, 2037method-of-use (U-3601)US 10952986
  • Jul 21, 2037formulationUS 10973795
  • Jul 21, 2037formulationUS 10973795
  • Jul 21, 2037formulationUS 10973795
  • Jul 21, 2037formulationUS 10973795
  • Jul 21, 2037formulationUS 11000498
  • Jul 21, 2037formulationUS 11000498
  • Jul 21, 2037formulationUS 11000498
  • Jul 21, 2037formulationUS 11000498
  • Jul 21, 2037formulationUS 11052061
  • Jul 21, 2037formulationUS 11052061
  • Jul 21, 2037formulationUS 11052061
  • Jul 21, 2037formulationUS 11052061
  • Jul 21, 2037formulationUS 11065224
  • Jul 21, 2037formulationUS 11065224
  • Jul 21, 2037formulationUS 11065224
  • Jul 21, 2037formulationUS 11065224
  • Jul 21, 2037method-of-use (U-3579)US 11400065
  • Jul 21, 2037method-of-use (U-3579)US 11400065
  • Jul 21, 2037method-of-use (U-3579)US 11400065
  • Jul 21, 2037method-of-use (U-3579)US 11400065
  • Jul 21, 2037formulationUS 11504347
  • Jul 21, 2037formulationUS 11504347
  • Jul 21, 2037formulationUS 11504347
  • Jul 21, 2037formulationUS 11504347
  • Jul 21, 2037method-of-use (U-3577)US 11602512
  • Jul 21, 2037method-of-use (U-3577)US 11602512
  • Jul 21, 2037method-of-use (U-3577)US 11602512
  • Jul 21, 2037method-of-use (U-3577)US 11602512
  • Jul 21, 2037method-of-use (U-3576)US 11602513
  • Jul 21, 2037method-of-use (U-3576)US 11602513
  • Jul 21, 2037method-of-use (U-3576)US 11602513
  • Jul 21, 2037method-of-use (U-3576)US 11602513
  • Jul 21, 2037formulationUS 11766418
  • Jul 21, 2037formulationUS 11766418
  • Jul 21, 2037formulationUS 11766418
  • Jul 21, 2037formulationUS 11766418
  • Jul 21, 2037method-of-use (U-3751)US 11826335
  • Jul 21, 2037formulationUS 11839597
  • Jul 21, 2037formulationUS 11839597
  • Jul 21, 2037formulationUS 11839597
  • Jul 21, 2037formulationUS 11839597
  • Jul 21, 2037formulationUS 11896572
  • Jul 21, 2037formulationUS 11896572
  • Jul 21, 2037formulationUS 11896572
  • Jul 21, 2037formulationUS 11896572
  • Jul 21, 2037method-of-use (U-3934)US 11986451
  • Jul 21, 2037method-of-use (U-3934)US 11986451
  • Jul 21, 2037method-of-use (U-3934)US 11986451
  • Jul 21, 2037method-of-use (U-3934)US 11986451
  • Jul 21, 2037formulationUS 12097175
  • Jul 21, 2037formulationUS 12097175
  • Jul 21, 2037formulationUS 12097175
  • Jul 21, 2037formulationUS 12097175
  • Jul 21, 2037method-of-use (U-4006)US 12097176
  • Jul 21, 2037method-of-use (U-4006)US 12097176
  • Jul 21, 2037method-of-use (U-4006)US 12097176
  • Jul 21, 2037method-of-use (U-4006)US 12097176
  • Jul 21, 2037formulationUS 12109186
  • Jul 21, 2037formulationUS 12109186
  • Jul 21, 2037formulationUS 12109186
  • Jul 21, 2037formulationUS 12109186
  • Jul 21, 2037formulationUS 12115142
  • Jul 21, 2037formulationUS 12115142
  • Jul 21, 2037formulationUS 12115142
  • Jul 21, 2037formulationUS 12115142
  • Jul 21, 2037formulationUS 12115143
  • Jul 21, 2037formulationUS 12115143
  • Jul 21, 2037formulationUS 12115143
  • Jul 21, 2037formulationUS 12115143
  • Jul 21, 2037formulationUS 12115144
  • Jul 21, 2037formulationUS 12115144
  • Jul 21, 2037formulationUS 12115144
  • Jul 21, 2037formulationUS 12115144
  • Jul 21, 2037formulationUS 12115145
  • Jul 21, 2037formulationUS 12115145
  • Jul 21, 2037formulationUS 12115145
  • Jul 21, 2037formulationUS 12115145
  • Jul 21, 2037method-of-use (U-4022)US 12128021
  • Jul 21, 2037method-of-use (U-4022)US 12128021
  • Jul 21, 2037method-of-use (U-4022)US 12128021
  • Jul 21, 2037method-of-use (U-4022)US 12128021
  • Jul 21, 2037formulationUS 12138239
  • Jul 21, 2037formulationUS 12138239
  • Jul 21, 2037formulationUS 12138239
  • Jul 21, 2037formulationUS 12138239
  • Jul 21, 2037formulationUS 12144793
  • Jul 21, 2037formulationUS 12144793
  • Jul 21, 2037formulationUS 12144793
  • Jul 21, 2037formulationUS 12144793
  • Jul 21, 2037formulationUS 12226377
  • Jul 21, 2037formulationUS 12226377
  • Jul 21, 2037formulationUS 12226377
  • Jul 21, 2037formulationUS 12226377
  • Jul 21, 2037method-of-use (U-4189)US 12303478
  • Jul 21, 2037method-of-use (U-4189)US 12303478
  • Jul 21, 2037method-of-use (U-4189)US 12303478
  • Jul 21, 2037method-of-use (U-4189)US 12303478
  • Sep 15, 2033patentUS 10213400*PED
  • Sep 15, 2033patentUS 10213400*PED
  • Sep 15, 2033patentUS 10864181*PED
  • Sep 15, 2033patentUS 10864181*PED
  • Sep 15, 2033patentUS 11253494*PED
  • Sep 15, 2033patentUS 11253494*PED
  • Sep 15, 2033patentUS 8772306*PED
  • Sep 15, 2033patentUS 8772306*PED
  • Sep 15, 2033patentUS 9050302*PED
  • Sep 15, 2033patentUS 9050302*PED
  • Sep 15, 2033patentUS 9486426*PED
  • Sep 15, 2033patentUS 9486426*PED
  • Mar 15, 2033method-of-use (U-2499)US 10213400
  • Mar 15, 2033method-of-use (U-2499)US 10213400
  • Mar 15, 2033method-of-use (U-1532)US 10864181
  • Mar 15, 2033method-of-use (U-3017)US 10864181
  • Mar 15, 2033method-of-use (U-3324)US 11253494
  • Mar 15, 2033method-of-use (U-3324)US 11253494
  • Mar 15, 2033method-of-use (U-3324)US 11986446
  • Mar 15, 2033method-of-use (U-3324)US 11986446
  • Mar 15, 2033method-of-use (U-1532)US 8772306
  • Mar 15, 2033method-of-use (U-1532)US 8772306
  • Mar 15, 2033method-of-use (U-1532)US 9050302
  • Mar 15, 2033method-of-use (U-1532)US 9050302
  • Mar 15, 2033method-of-use (U-1532)US 9486426
  • Mar 15, 2033method-of-use (U-1532)US 9486426
  • Jan 11, 2033formulationUS 10195168
  • Jan 11, 2033method-of-use (U-2938)US 10675258
  • Jan 11, 2033formulationUS 11554102
  • Jan 11, 2033formulationUS 8591922
  • Jan 11, 2033formulationUS 8901173
  • Jan 11, 2033formulationUS 9132107

FDA exclusivities (17)

  • Oct 16, 2031ODE-494Orphan Drug (7y)
  • Oct 16, 2031ODE-494Orphan Drug (7y)
  • Oct 16, 2031ODE-494Orphan Drug (7y)
  • Oct 16, 2031ODE-494Orphan Drug (7y)
  • May 1, 2030ODE-431Orphan Drug (7y)3.7y
  • May 1, 2030ODE-431Orphan Drug (7y)3.7y
  • May 1, 2030ODE-431Orphan Drug (7y)3.7y
  • May 1, 2030ODE-431Orphan Drug (7y)3.7y
  • Aug 12, 2028ODE-369Orphan Drug (7y)2.0y
  • Jan 21, 2028PEDPediatric (6mo bonus)1.4y
  • Jul 21, 2027ODE-361Orphan Drug (7y)340d
  • May 1, 2026NPNP
  • May 1, 2026NPNP
  • May 1, 2026NPNP
  • May 1, 2026NPNP
  • Apr 26, 2026PEDPediatric (6mo bonus)
  • Oct 26, 2025ODE-231Orphan Drug (7y)

News(4)

  • Jazz to buy rare epilepsy drugmaker in potentially $1.3B deal
    Actio Biosciences, which will receive $820 million up front in the deal, adds to a major upswing in private biotech buyouts seen throughout this year.
    biopharma_dive · 4d ago
  • Takeda approval ushers in new wave of sleep drugs
    An FDA nod mostly clears the way for Orzeyful to enter, by Wall Street estimates, a multibillion-dollar market for drugs that boost “orexin” proteins.
    biopharma_dive · 8d ago
  • STAT+: Takeda’s narcolepsy drug approved by the FDA, seen as a boon for new class of treatments
    The FDA approved a novel type of treatment for narcolepsy made by Takeda, backing a new drug class that scientists hope can be used to treat other conditions.
    stat · 9d ago
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    biospace · 24d ago
brand
Xywav
generic
sodium oxybate
MOA
GABA-B receptor agonist
indication
Cataplexy
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 30m ago
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