drug
(calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate)
Marketedupdated 5mo agoby $JAZZ Jazz Pharmaceuticals plc
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 11 investigational indications.
all catalysts(1)
Trials studying (calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate)
- phase3A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
- phase2Extended-release Sodium Oxybate in Children
- phase4A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jul 21, 2027
290 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)3.6y
- May 1, 2030ODE-431Orphan Drug (7y)3.6y
- May 1, 2030ODE-431Orphan Drug (7y)3.6y
- May 1, 2030ODE-431Orphan Drug (7y)3.6y
- Aug 12, 2028ODE-369Orphan Drug (7y)1.9y
- Jan 21, 2028PEDPediatric (6mo bonus)1.3y
- Jul 21, 2027ODE-361Orphan Drug (7y)290d
- May 1, 2026NPNP
- May 1, 2026NPNP
- May 1, 2026NPNP
- May 1, 2026NPNP
- Apr 26, 2026PEDPediatric (6mo bonus)
- Oct 26, 2025ODE-231Orphan Drug (7y)
News(6)
- New Jazz cancer drug approval could drive blockbuster salesZiihera can now be used as an initial treatment for all HER2-positive gastroesophageal adenocarcinomas, dramatically expanding the drug’s market potential.biopharma_dive · 1mo ago
- Takeda leads wave of orexin drugs with potential to upend narcolepsy marketThe FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market.biospace · 1mo ago
- Jazz to buy rare epilepsy drugmaker in potentially $1.3B dealActio 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 · 1mo ago
- Takeda approval ushers in new wave of sleep drugsAn 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 · 1mo ago
- STAT+: Takeda’s narcolepsy drug approved by the FDA, seen as a boon for new class of treatmentsThe 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 · 1mo ago
- The FDA’s 505(b)(2) pathway is an underestimated engine of value creationThe 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 · 2mo ago
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