small molecule

XYREM

SODIUM OXYBATE

Loss of exclusivitySeptember 2033latest FDA-listed patent expiry
CompanyJazz PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand nameXYREM
Active ingredientSODIUM OXYBATE
Strength0.5GM/ML
Dosage formSOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalJuly 2002
Marketing statusRX

Listed patents

PatentExpiresType
8772306*PEDSeptember 2033
9486426*PEDSeptember 2033
9050302*PEDSeptember 2033
11253494*PEDSeptember 2033
10213400*PEDSeptember 2033
10864181*PEDSeptember 2033
10213400March 2033use U-2499
11253494March 2033use U-3324
9486426March 2033use U-1532
9050302March 2033use U-1532
8772306March 2033use U-1532
11986446March 2033use U-3324
10864181March 2033use U-1532

Regulatory exclusivity

CodeExpires
PEDApril 2026
ODE-231October 2025

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

XYREM patent cliff — loss of exclusivity September 2033 | CliffBio