Xyrem Drug Patent Profile

Which patents cover Xyrem, and when can generic versions of Xyrem launch?

Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in twenty-one countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xyrem

Xyrem was eligible for patent challenges on July 17, 2006.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (sodium oxybate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for Xyrem

International Patents:	33
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	29
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Xyrem
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Xyrem
What excipients (inactive ingredients) are in Xyrem?	Xyrem excipients list
DailyMed Link:	Xyrem at DailyMed

See drug prices for Xyrem

Pharmacology for Xyrem

Drug Class	Central Nervous System Depressant
Physiological Effect	Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for Xyrem

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for XYREM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XYREM	Oral Solution	sodium oxybate	500 mg/mL	021196	1	2010-07-08

US Patents and Regulatory Information for Xyrem

Xyrem is protected by seven US patents and two FDA Regulatory Exclusivities.

Patents protecting Xyrem

FDA Regulatory Exclusivity protecting Xyrem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y

EU/EMA Drug Approvals for Xyrem

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma Ltd	Xyrem	sodium oxybate	EMEA/H/C/000593 Treatment of narcolepsy with cataplexy in adult patients.	Authorised	no	no	no	2005-10-13
D&A Pharma	Hopveus	sodium oxybate	EMEA/H/C/004962 Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.	Refused	no	no	no		2020-07-06

International Patents for Xyrem

See the table below for patents covering Xyrem around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0038672
Poland	2961399
Denmark	1140061
European Patent Office	1140061	SOLUTIONS DE SEL D'HYDROXYBUTYRATE STABLES ET SAINES AU PLAN MICROBIOLOGIQUE, POUR LE TRAITEMENT DE LA NARCOLEPSIE (MICROBIOLOGICALLY SOUND AND STABLE SOLUTIONS OF GAMMA-HYDROXYBUTYRATE SALT FOR THE TREATMENT OF NARCOLEPSY)
Israel	143733

Supplementary Protection Certificates for Xyrem

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
0186405	SPC/GB00/021	United Kingdom		PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313