Pharsight

Xywav is owned by Jazz.

Xywav contains Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate.

Xywav has a total of 21 drug patents out of which 1 drug patent has expired.

Expired drug patents of Xywav are:

US8731963

Xywav was authorised for market use on 21 July, 2020.

Xywav is available in solution;oral dosage forms.

Xywav can be used as method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered, method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered., treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb administered between 2 and 4 hours after eating, method of treating a patient with a prescription drug using a computer database in a computer system for distribution, treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb, method of reducing adverse effects in patients suffering from excessive daytime sleepiness and/or cataplexy in narcolepsy who are concomitantly administered sodium oxybate and divalproex sodium, method of treating patients with idiopathic hypersomnia with sodium oxybate when divalproex sodium is concomitantly administered; method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered., method of reducing adverse effects in patients who are concomitantly administered a salt of gamma-hydroxybutyrate and divalproex sodium; method of treating patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered.

The generics of Xywav are possible to be released after 19 September, 2037.

Application	Filing Date	Opposition Party	Legal Status
EP17200764A	2020-09-11	Ter Meer Steinmeister & Partner Patentanwälte mbB	Granted and Under Opposition
EP17200764A	2020-09-10	Hexal AG	Granted and Under Opposition
EP17200764A	2020-09-02	Zentiva, k.s.	Granted and Under Opposition
EP17200764A	2020-03-16	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Granted and Under Opposition
EP14709858A	2018-08-14	Ter Meer Steinmeister & Partner Patentanwälte mbB	Revoked
EP14709858A	2018-08-14	Hexal AG	Revoked
EP14709858A	2018-07-23	Hoffmann Eitle	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US9050302	March, 2016	Terminated-Denied	Jazz Pharmaceuticals Ireland Limited	RANBAXY INC
US8772306	February, 2016	Terminated-Denied	Jazz Pharmaceutical, Inc.	Amneal Pharmaceuticals LLC
US8772306	October, 2015	Terminated-Settled	Jazz Pharmaceutical, Inc.	Ranbaxy, Inc.
US8772306	October, 2015	Terminated-Denied	Jazz Pharmaceutical, Inc.	Par Pharmaceutical, Inc.
US8731963	September, 2015	FWD Entered	Jazz Pharmaceuticals, Inc.	Par Pharmaceutical, Inc.

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8731963	JAZZ	Sensitive drug distribution system and method	Dec, 2022 (3 months ago)
US8731963 (Pediatric)	JAZZ	Sensitive drug distribution system and method	Jun, 2023 (2 months from now)
US11554102	JAZZ	NA	Jan, 2033 (9 years from now)
US10675258	JAZZ	Method of using gamma-hydroxybutyrate compositions for the treatment of disorders	Jan, 2033 (9 years from now)
US8901173	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (9 years from now)
US10195168	JAZZ	Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders	Jan, 2033 (9 years from now)
US8591922	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (9 years from now)
US9132107	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (9 years from now)
US11253494	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US8772306	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US9050302	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US10213400	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US9486426	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US10864181	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US9050302 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US8772306 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US10864181 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US11253494 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US9486426 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US10213400 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (10 years from now)
US11426373	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Sep, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Aug 12, 2028
New Product (NP)	Jul 21, 2023
New Indication (I)	Aug 12, 2024

Drugs and Companies using CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE ingredient

Market Authorisation Date: 21 July, 2020

Treatment: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution; Treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb; Method of reducing adverse effects in patients who are concomitantly administered a salt of gamma-hydroxybutyrate and divalproex sodium; Method of treating patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered; Method of treating patients with idiopathic hypersomnia with sodium oxybate when divalproex sodium is concomitantly administered; Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.; Method of reducing adverse effects in patients suffering from excessive daytime sleepiness and/or cataplexy in narcolepsy who are concomitantly administered sodium oxybate and divalproex sodium; Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered; Treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb administered between 2 and 4 hours after eating

Dosage: SOLUTION;ORAL