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Serving leading biopharmaceutical companies globally:

Citi
Baxter
Mallinckrodt
US Army
Chinese Patent Office
Healthtrust
UBS
McKesson
Cipla
Medtronic

Generated: January 22, 2018

DrugPatentWatch Database Preview

NAMZARIC Drug Profile

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When do Namzaric patents expire, 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 three Paragraph IV challenges.

This drug has fifty-eight 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.

US Patents and Regulatory Information for NAMZARIC

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 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ 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 206439-002 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 ➤ 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 206439-004 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe ➤ 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 ➤ 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 NAMZARIC

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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Paragraph IV (Patent) Challenges for NAMZARIC
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 21 mg/10 mg ➤ Subscribe 9/23/2016
➤ Subscribe Capsules 7 mg/10 mg ➤ Subscribe 9/26/2016
➤ Subscribe Capsules 14 mg/10 mg and 28 mg/10 mg ➤ Subscribe 5/18/2015

Non-Orange Book US Patents for 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
2,012,058,182 ➤ Subscribe
7,619,007 Method and composition for administering an NMDA receptor antagonist to a subject ➤ Subscribe
8,426,472 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 NAMZARIC

Supplementary Protection Certificates for NAMZARIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Baxter
Boehringer Ingelheim
Farmers Insurance
Colorcon
McKesson
Moodys
Fish and Richardson

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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