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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,338,486

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Which drugs does patent 8,338,486 protect, and when does it expire?


Patent 8,338,486 protects NAMZARIC and is included in one NDA. There have been three Paragraph IV challenges on Namzaric.

This patent has fifty-seven patent family members in eighteen countries.

Summary for Patent: 8,338,486

Title:Methods for the treatment of CNS-related conditions
Abstract: The invention provides methods for administering extended release memantine in combination with immediate release donepezil to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt thereof in combination with donepezil is administered to a patient suffering from a neurological condition, such as Alzheimer's disease, Parkinson's disease or dementia. The extended release form of memantine achieves particular pharmacokinetic criteria such as change in plasma concentration of memantine over time and ratio of maximum memantine plasma concentration to mean memantine plasma concentration.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Meyerson; Laurence R. (Las Vegas, NV)
Assignee: Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:13/536,763
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXYesNo► Subscribe► Subscribe MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-001Dec 23, 2014ABRXYesNo► Subscribe► Subscribe MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-004Jul 18, 2016RXYesNo► Subscribe► Subscribe MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014ABRXYesYes► Subscribe► Subscribe MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
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Non-Orange Book Patents for Patent: 8,338,486

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
8,580,858Compositions for the treatment of CNS-related conditions► Subscribe
8,426,472Method and composition for administering an NMDA receptor antagonist to a subject► Subscribe
2,012,045,508► Subscribe
8,058,291Methods and compositions for the treatment of CNS-related conditions► Subscribe
8,168,209Method and composition for administering an NMDA receptor antagonist to a subject► Subscribe
8,293,794Methods and compositions for the treatment of CNS-related conditions► Subscribe
8,283,379Methods and compositions for the treatment of CNS-related conditions► Subscribe
8,329,752Composition for administering an NMDA receptor antagonist to a subject► Subscribe
8,362,085Method for administering an NMDA receptor antagonist to a subject► Subscribe
8,338,485Compositions for the treatment of CNS-related conditions► 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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International Patent Family for Patent: 8,338,486

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2007522249► Subscribe
Japan2008520736► Subscribe
Japan2009173669► Subscribe
South Korea20070112763► Subscribe
South Korea101301429► Subscribe
South Korea20070116996► Subscribe
South Korea101406456► Subscribe
South Korea20060124731► Subscribe
Mexico2007006120► Subscribe
Mexico2007012374► 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.

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Serving leading biopharmaceutical companies globally:

Citi
Farmers Insurance
Cerilliant
Federal Trade Commission
Fish and Richardson
Teva
Healthtrust
Cipla
Harvard Business School
Moodys

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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