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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	Final Written Decision	Jazz Pharmaceuticals, Inc.	Par Pharmaceutical, Inc. et al.
US7668730	August, 2015	FWD Entered	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG
US7668730	January, 2015	Final Written Decision	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC. et al.
US7668730	July, 2014	Terminated-Denied	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC.
US7668730	May, 2008	Decision	Dayton T. Reardan et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8731963	JAZZ PHARMS	Sensitive drug distribution system and method	Dec, 2022 (9 months ago)
US8731963 (Pediatric)	JAZZ PHARMS	Sensitive drug distribution system and method	Jun, 2023 (3 months ago)
US7668730	JAZZ PHARMS	Sensitive drug distribution system and method	Jun, 2024 (8 months from now)
US7668730 (Pediatric)	JAZZ PHARMS	Sensitive drug distribution system and method	Dec, 2024 (1 year, 2 months from now)
US9486426	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US10213400	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US9050302	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US8772306	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US10864181	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US11253494	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (9 years from now)
US10864181 (Pediatric)	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US10213400 (Pediatric)	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US8772306 (Pediatric)	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US9486426 (Pediatric)	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US9050302 (Pediatric)	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US11253494 (Pediatric)	JAZZ PHARMS	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)

Xyrem is owned by Jazz Pharms.

Xyrem contains Sodium Oxybate.

Xyrem has a total of 16 drug patents out of which 2 drug patents have expired.

Expired drug patents of Xyrem are:

US8731963
US8731963*PED

Xyrem was authorised for market use on 17 July, 2002.

Xyrem is available in solution;oral dosage forms.

Xyrem can be used as 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 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 a patient with a prescription drug using a computer database in a computer system for distribution, method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered..

The generics of Xyrem are possible to be released after 15 September, 2033.

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Oct 26, 2025
Pediatric Exclusivity (PED)	Apr 26, 2026

Drugs and Companies using SODIUM OXYBATE ingredient

Market Authorisation Date: 17 July, 2002

Treatment: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution; Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy pa...

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
500 mg/mL	08 Jul, 2010	1	17 Jan, 2017	16 Jun, 2024	Eligible

Strength	Dosage	Availability
0.5GM/ML	SOLUTION;ORAL	Prescription

XYREM family patents

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Xyrem patents expiration

XYREM family patents

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