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

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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 · 16 unexpired

25 Orange Book listing rows for 16 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 12138233	use U-4044 · sets the listed date	22 Feb 2041	listed 11 Dec 2024
US 12582622	use U-4044 · sets the listed date	22 Feb 2041	listed 13 Apr 2026
US 11426373	use U-3432	19 Sep 2037	listed 27 Sep 2022
US 10213400	use U-2499	15 Sep 2033	2 listing rows
US 10213400 listing row	use U-2499	15 Mar 2033	listed 19 Aug 2020
US 10213400 listing row	pediatric extension	15 Sep 2033
US 10864181	use U-3017	15 Sep 2033	2 listing rows
US 10864181 listing row	use U-3017	15 Mar 2033	listed 13 Jan 2021
US 10864181 listing row	pediatric extension	15 Sep 2033
US 11253494	use U-3323, U-3324	15 Sep 2033	3 listing rows
US 11253494 listing row	use U-3323	15 Mar 2033	listed 15 Mar 2022
US 11253494 listing row	use U-3324	15 Mar 2033	listed 15 Mar 2022
US 11253494 listing row	pediatric extension	15 Sep 2033
US 8772306	use U-1532, U-3198	15 Sep 2033	3 listing rows
US 8772306 listing row	use U-1532	15 Mar 2033	listed 19 Aug 2020
US 8772306 listing row	use U-3198	15 Mar 2033	listed 19 Aug 2020
US 8772306 listing row	pediatric extension	15 Sep 2033
US 9050302	use U-1532	15 Sep 2033	2 listing rows
US 9050302 listing row	use U-1532	15 Mar 2033	listed 19 Aug 2020
US 9050302 listing row	pediatric extension	15 Sep 2033
US 9486426	use U-1532	15 Sep 2033	2 listing rows
US 9486426 listing row	use U-1532	15 Mar 2033	listed 19 Aug 2020
US 9486426 listing row	pediatric extension	15 Sep 2033
US 11986446	use U-3017, U-3324	15 Mar 2033	2 listing rows
US 11986446 listing row	use U-3017	15 Mar 2033	listed 18 Jun 2024
US 11986446 listing row	use U-3324	15 Mar 2033	listed 18 Jun 2024
US 10195168	drug product	11 Jan 2033	listed 19 Aug 2020
US 10675258	use U-2938	11 Jan 2033	listed 19 Aug 2020
US 11554102	drug product	11 Jan 2033	listed 8 Feb 2023
US 8591922	drug product	11 Jan 2033	listed 19 Aug 2020
US 8901173	drug product	11 Jan 2033	listed 19 Aug 2020
US 9132107	drug product	11 Jan 2033	listed 19 Aug 2020

Exclusivities · 3 unexpired

ODE-369	orphan drug (7 years)	12 Aug 2028
PED	pediatric (6 months added)	21 Jan 2028
ODE-361	orphan 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 · product	Form	Strength	Approved	Listed expiry
212690 · 001 · RLD	solution, oral	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	21 Jul 2020	22 Feb 2041