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 seven 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. 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 nineteen 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: | 32 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Patent Applications: | 2,661 |
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 |


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
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
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Sensitive drug distribution system and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for XYREM
See the table below for patents covering XYREM around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 111317730 | ⤷ Try a Trial | |
Australia | 2014223373 | ⤷ Try a Trial | |
Hong Kong | 1256965 | ⤷ Try a Trial | |
Singapore | 11201505029Q | ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS | ⤷ Try a Trial |
China | 105073106 | Administration of gamma hydroxybutyrate with monocarboxylate transporters | ⤷ Try a Trial |
Denmark | 3335708 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XYREM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0788511 | SPC/GB08/036 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | 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 |
0290047 | 97C0108 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522 |
1912999 | 1490062-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
1856135 | 2090014-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
0806968 | SPC/GB07/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |