XYREM Drug Patent Profile

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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two 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. 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 thirteen 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.

Indicators of Generic Entry

Summary for XYREM

International Patents:	32
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	4,246
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

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 nine US patents and three 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
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
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes

International Patents for XYREM

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20150125943	모노카복실레이트 운반체와 함께 감마 하이드록시부티레이트의 투여 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
Spain	2775779
South Korea	102239042
Croatia	P20200215
Japan	5204685

Supplementary Protection Certificates for XYREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119