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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
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US Department of Justice
Cerilliant
Deloitte
Daiichi Sankyo
Citi
Merck
Moodys
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Generated: August 20, 2017

DrugPatentWatch Database Preview

NAMZARIC Drug Profile

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What is the patent landscape for Namzaric, and when can generic versions of Namzaric launch?

Namzaric is a drug marketed by Forest Labs Llc and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

Summary for Tradename: NAMZARIC

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NAMZARIC at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014ABRXYesYes► Subscribe► Subscribe ► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-004Jul 18, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014ABRXYesYes► Subscribe► SubscribeY► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-004Jul 18, 2016RXYesNo► Subscribe► Subscribe ► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-004Jul 18, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: NAMZARIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-001Dec 23, 2014► Subscribe► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014► Subscribe► Subscribe
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Paragraph IV activity for: NAMZARIC

Drugname Dosage Strength RLD Submissiondate
memantine hydrochloride extended-release and donepezil hydrochlorideCapsules14 mg/10 mg and 28 mg/10 mgNamzaric5/18/2015

Non-Orange Book Patents for Tradename: NAMZARIC

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
2,012,045,508► Subscribe
7,619,007Method and composition for administering an NMDA receptor antagonist to a subject► Subscribe
2,012,058,182► Subscribe
8,426,472Method and composition for administering an NMDA receptor antagonist to a subject► 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 Tradename: NAMZARIC

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005079773► Subscribe
Japan2009173669► Subscribe
European Patent Office1734920► Subscribe
BrazilPI0607017► Subscribe
China101060830► 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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Supplementary Protection Certificates for Tradename: NAMZARIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998Austria► SubscribePRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
C/GB97/023United Kingdom► SubscribePRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Queensland Health
Dow
Fuji
Express Scripts
Argus Health
Medtronic
Daiichi Sankyo
Cerilliant

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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