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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Chinese Patent Office
Daiichi Sankyo
US Army
QuintilesIMS
Farmers Insurance
Teva
US Department of Justice

Generated: June 24, 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 sixty-nine patent family members in nineteen 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
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 7 mg/10 mg ➤ Subscribe 2016-09-26
➤ Subscribe Capsules 21 mg/10 mg ➤ Subscribe 2016-09-23
➤ Subscribe Capsules 14 mg/10 mg and 28 mg/10 mg ➤ Subscribe 2015-05-18

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
8,426,472 Method and composition for administering an NMDA receptor antagonist to a subject ➤ Try a Free Trial
2,012,045,508 ➤ Try a Free Trial
7,619,007 Method and composition for administering an NMDA receptor antagonist to a subject ➤ Try a Free Trial
2,012,058,182 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NAMZARIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998 Austria ➤ Try a Free Trial 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 ➤ Try a Free Trial 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 hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Julphar
Farmers Insurance
Cerilliant
McKesson
Colorcon
US Army
Express Scripts

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