Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00546	8772306	IPR	Amneal Pharmaceuticals LLC	Institution Denied	2016-02-02	—
IPR2016-00024	8772306	IPR	Ranbaxy, Inc.	Terminated-Settled	2015-10-07	—
IPR2016-00002	8772306	IPR	Par Pharmaceutical, Inc.	Institution Denied	2015-10-06	—
IPR2016-00738	9050302	IPR	RANBAXY INC	Institution Denied	2016-03-10	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 cases on OB patents (3 active) from PACER

Case	Court	Filed	Status	Judge
JAZZ PHARMACEUTICALS IRELAND LIMITED v. TRIS PHARMA, INC. 2:2026cv01740 15 patentscalcium, magnesium, potassium, and sodium oxybates	D.N.J.	2026-02-20	Active	—
JAZZ PHARMACEUTICALS IRELAND LIMITED v. GRANULES INDIA LIMITED 2:2025cv14606 14 patentsANDA 220725calcium, magnesium, potassium, and sodium oxybates	D.N.J.	2025-08-13	Active	—
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 1:2024cv01384 1 patentsodium oxybate, calcium oxybate, magnesium oxybate, potassium oxybate	D. Del.	2024-12-17	Terminated 2025-01-07	—
JAZZ PHARMACEUTICALS IRELAND LIMITED v. TEVA PHARMACEUTICALS, INC. 2:2023cv01617 13 patentsANDA 216884calcium, magnesium, potassium, and sodium oxybates	D.N.J.	2023-03-21	Terminated 2023-12-15	—
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD. et al 2:2023cv00329 2 patentsANDA 215911calcium, magnesium, potassium, and sodium oxybates	D.N.J.	2023-01-20	Terminated 2023-02-16	—
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC. et al 2:2021cv14271 10 patentsANDA 215911calcium, magnesium, potassium, and sodium oxybates	D.N.J.	2021-07-28	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xywav (2023)

Total Spending

$168.7M

Total Claims

10,622

Beneficiaries

1,332

Avg Cost/Unit

$34.48

Spending Trend

$3.4M(2020)→$84.2M(2021)→$125.6M(2022)→$168.7M(2023)

YoY Change:+6.0%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

14 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML

RLD

16 patents3 exclusivities▴

SOLUTION;ORAL | Approved: Jul 21, 2020

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8591922	Jan 11, 2033	—	—	Yes	—	—
8772306	Mar 15, 2033PED: Sep 15, 2033	PED	—	—		—
8901173	Jan 11, 2033	—	—	Yes	—	—
9050302	Mar 15, 2033PED: Sep 15, 2033	PED	—	—		—
9132107	Jan 11, 2033	—	—	Yes	—	—
9486426	Mar 15, 2033PED: Sep 15, 2033	PED	—	—		—
10195168	Jan 11, 2033	—	—	Yes	—	—
10213400	Mar 15, 2033PED: Sep 15, 2033	PED	—	—		—
10675258	Jan 11, 2033	—	—	—		—
10864181	Mar 15, 2033PED: Sep 15, 2033	PED	—	—		—
11253494	Mar 15, 2033PED: Sep 15, 2033	PED	—	—		—
11426373	Sep 19, 2037	—	—	—		—
11554102	Jan 11, 2033	—	—	Yes	—	—
11986446	Mar 15, 2033	—	—	—		—
12138233	Feb 22, 2041	—	—	—		—
12582622	Feb 22, 2041	—	—	—		—