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Generated: June 28, 2017
What is the patent landscape for Xyrem, and what generic Xyrem alternatives are available?
Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.| Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 15 |
| Clinical Trials: see list | 25 |
| Patent Applications: see list | 5,962 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | XYREM at DailyMed |
| Drug Class | Central Nervous System Depressant |
| Physiological Effect | Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity |
| 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 | AA | RX | Yes | Yes | 8,859,619 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | 7,851,506 | ► Subscribe | ► Subscribe | |||||||||||||||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | 8,952,062 | ► Subscribe | ► Subscribe | |||||||||||||||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | 9,539,330 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | 8,457,988 | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| sodium oxybate | Oral Solution | 500 mg/mL | Xyrem | 7/8/2010 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,472,431 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy | ► Subscribe | |||||||||||||||||||||||||||
| 8,952,029 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | ► Subscribe | |||||||||||||||||||||||||||
| 7,797,171 | Sensitive drug distribution system and method | ► Subscribe | |||||||||||||||||||||||||||
| 8,461,203 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taiwan | 201511752 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 0038672 | ► Subscribe | |||||||||||||||||||||||||||
| China | 105073106 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1140061 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4374441 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0041 | France | ► Subscribe | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 | ||||||||||||||||||||||||||
| 2015 00014 | Denmark | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 | ||||||||||||||||||||||||||
| C0022 | France | ► Subscribe | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 | ||||||||||||||||||||||||||
| C/GB98/040 | United Kingdom | ► Subscribe | PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508 | ||||||||||||||||||||||||||
| C0055 | France | ► Subscribe | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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