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
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 |


Anatomical Therapeutic Chemical (ATC) Classes for XYREM
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 |