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Serving leading biopharmaceutical companies globally:

Express Scripts
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Cipla
UBS
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Chinese Patent Office
US Army
Julphar
Daiichi Sankyo
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Generated: January 20, 2018

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DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for donepezil hydrochloride; memantine hydrochloride and what is the scope of donepezil hydrochloride; memantine hydrochloride patent protection?

Donepezil hydrochloride; memantine hydrochloride
is the generic ingredient in two branded drugs marketed by Amneal Pharms and Forest Labs Llc, and is included in two NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride; memantine hydrochloride has fifty-eight patent family members in eighteen countries.

There are thirty-one drug master file entries for donepezil hydrochloride; memantine hydrochloride. Two suppliers are listed for this compound.
Summary for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Pharmacology for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

US Patents and Regulatory Information for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 ➤ Subscribe ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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
2,012,058,182 ➤ Subscribe
8,426,472 Method and composition for administering an NMDA receptor antagonist to a subject ➤ Subscribe
7,619,007 Method and composition for administering an NMDA receptor antagonist to a subject ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Supplementary Protection Certificates for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998 Austria ➤ Subscribe PRODUCT 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/GB97/023 United Kingdom ➤ Subscribe PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Argus Health
Moodys
Queensland Health
Citi
Merck
Express Scripts
Cantor Fitzgerald

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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