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XYREM Drug Profile

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When do Xyrem patents expire, and when can generic versions of Xyrem launch?

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

This drug has forty-six patent family members in twenty-three 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. One supplier is 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 twelve 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:	46
US Patents:	14
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	18
Patent Applications:	2,743
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

Paragraph IV (Patent) Challenges for XYREM

Tradename	Dosage	Ingredient	NDA	Submissiondate
XYREM	SOLUTION;ORAL	sodium oxybate	021196	2010-07-08

US Patents and Regulatory Information for 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
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

International Patents for XYREM

Country	Patent Number	Estimated Expiration
Denmark	3335708
Austria	238783
Poland	3335708

Supplementary Protection Certificates for XYREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115