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Lumryz

(Non-extended-release oxybates)

Phase 2Small molecule

Jazz Pharmaceuticals

Lumryz is one of 43 small molecule programs targeting Children. It is currently in Phase 2.

1

Indications

1

Total Trials

1

Active Trials

42

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

42

Patents

Pipeline

Status by Indication[3][1]

Indication

ChildrenRecruiting

ChildrenPhase 2

Recruiting

Competition

Competitive Landscape

58 competitors in Children

#DrugCompanyPhaseTrials

Promacta

Gleevec

Ozempic

Oncaspar

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Velcade

SShilpa Grover, MD, MPH

Byetta

Neurontin

VViatris Specialty LLC

Somavaratan

Xyrem

Jazz Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Children

NCT06809803

Clinical

Trials by Indication[1]

Children1 trial

Extended-release Sodium Oxybate in Children

Recruiting·SStanford University·Phase 2·NCT06809803·36 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 17, 2002

XYREM

NDA NDA021196

May 1, 2023

LUMRYZ

NDA NDA214755

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Non-extended-release oxybates. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Non-extended-release oxybates compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Non-extended-release oxybates. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214755). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lumryz. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Jazz Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Mar 15, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9050302Mar 15, 2033

10864181Mar 15, 2033

8772306Mar 15, 2033

9486426Mar 15, 2033

10213400Mar 15, 2033

37 more patents

9486426*PEDSep 15, 2033

9050302*PEDSep 15, 2033

10213400*PEDSep 15, 2033

8772306*PEDSep 15, 2033

11253494*PEDSep 15, 2033

10864181*PEDSep 15, 2033

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