← Patent-cliff monitor small molecule XYREM SODIUM OXYBATE
Loss of exclusivity September 2033 latest FDA-listed patent expiry
Drug detail Brand name XYREM Active ingredient SODIUM OXYBATE Strength 0.5GM/ML Dosage form SOLUTION Route ORAL Modality Small molecule FDA approval July 2002 Marketing status RX
Listed patents Patent Expires Type 8772306*PED September 2033 — 9486426*PED September 2033 — 9050302*PED September 2033 — 11253494*PED September 2033 — 10213400*PED September 2033 — 10864181*PED September 2033 — 10213400 March 2033 use U-2499 11253494 March 2033 use U-3324 9486426 March 2033 use U-1532 9050302 March 2033 use U-1532 8772306 March 2033 use U-1532 11986446 March 2033 use U-3324 10864181 March 2033 use U-1532
Regulatory exclusivity Code Expires PED April 2026 ODE-231 October 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.