XYREM Drug Patent Profile
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When do Xyrem patents expire, and what generic alternatives are available?
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-three 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 fifteen 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: | 33 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 29 |
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 | |||
>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 |
---|---|---|---|
Singapore | 11201505029Q | ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS | ⤷ Try a Trial |
Brazil | 112015021012 | administração de gama hidroxibutirato com transportador de monocarboxilatos | ⤷ Try a Trial |
European Patent Office | 1316309 | ⤷ Try a Trial | |
Hong Kong | 1256965 | γ羥基丁酸與單羧酸轉運蛋白的施用 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) | ⤷ Try a Trial |
Austria | 238783 | ⤷ 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 |
---|---|---|---|---|
1666481 | 17C1031 | France | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
2822954 | SPC/GB18/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
1713823 | 1490064-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
2673237 | LUC00111 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326 |
2203431 | 92666 | Luxembourg | ⤷ Try a Trial | 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 |