cliffwatch

calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate · Jazz · NDA 212690

Xywav

Earliest generic entry, as listed
22 Feb 2041

Blocked by patent: US 12138233, US 12582622. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 25 unexpired

PatentClaimsExpires
US 12138233use U-404422 Feb 2041
US 12582622use U-404422 Feb 2041
US 11426373use U-343219 Sep 2037
US 10213400—15 Sep 2033
US 10864181—15 Sep 2033
US 11253494—15 Sep 2033
US 8772306—15 Sep 2033
US 9050302—15 Sep 2033
US 9486426—15 Sep 2033
US 10213400use U-249915 Mar 2033
US 10864181use U-301715 Mar 2033
US 11253494use U-332415 Mar 2033
US 11253494use U-332315 Mar 2033
US 11986446use U-332415 Mar 2033
US 11986446use U-301715 Mar 2033
US 8772306use U-153215 Mar 2033
US 8772306use U-319815 Mar 2033
US 9050302use U-153215 Mar 2033
US 9486426use U-153215 Mar 2033
US 10195168product11 Jan 2033
US 10675258use U-293811 Jan 2033
US 11554102product11 Jan 2033
US 8591922product11 Jan 2033
US 8901173product11 Jan 2033
US 9132107product11 Jan 2033

Exclusivities · 3 unexpired

ODE-369orphan drug (7 years)12 Aug 2028
PEDpediatric (6 months added)21 Jan 2028
ODE-361orphan drug (7 years)21 Jul 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
212690 · 001 · RLDsolution, oral0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML22 Feb 2041