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Last Updated: May 26, 2022

XYREM Drug Patent 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 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

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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

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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 administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS WHO ARE CONCOMITANTLY ADMINISTERED A SALT OF GAMMA-HYDROXYBUTYRATE AND DIVALPROEX SODIUM

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED

Sensitive drug distribution system and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sensitive drug distribution system and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XYREM

INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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

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) See Plans and Pricing
Spain 2775779 See Plans and Pricing
South Korea 102239042 See Plans and Pricing
Croatia P20200215 See Plans and Pricing
Japan 5204685 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XYREM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 16C0018 France See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431 92666 Luxembourg See Plans and Pricing PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
McKinsey

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