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Last Updated: March 29, 2023

Details for Patent: 8,039,009


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Which drugs does patent 8,039,009 protect, and when does it expire?

Patent 8,039,009 protects NAMENDA XR and NAMZARIC and is included in two NDAs.

Protection for NAMENDA XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ten patent family members in nine countries.

Summary for Patent: 8,039,009
Title:Modified release formulations of memantine oral dosage forms
Abstract: The present invention provides pharmaceutical compositions given once daily containing at least one therapeutically active ingredient selected from the group consisting of memantine and a pharmaceutically acceptable salt of memantine, and a pharmaceutically acceptable polymeric matrix carrier. The dosage forms of the invention sustain the release of the therapeutically active agent from about 4 to about 24 hours when said dosage form is exposed to aqueous solutions. following entry of said form into a use environment, wherein said dosage form has a dissolution rate of more than about 80% after passage of about 6 hours to about 12 hours following said entry into said use environment.
Inventor(s): Rastogi; Suneel K. (Island Park, NY), Rao; Niranjan (Belle Mead, NJ), Periclou; Antonia (Jersey City, NJ), Abramowitz; Wattanaporn (Hillsborough, NJ), Dedhiya; Mahendra G. (Pomona, NY), Mahashabde; Shashank (Kendall Park, NJ)
Assignee: Forest Laboratories Holdings Limited (BM)
Application Number:11/155,330
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,039,009
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 8,039,009

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,039,009

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2005265031 See Plans and Pricing
Brazil PI0512177 See Plans and Pricing
Canada 2569015 See Plans and Pricing
China 1968684 See Plans and Pricing
Eurasian Patent Organization 011446 See Plans and Pricing
Eurasian Patent Organization 200700049 See Plans and Pricing
European Patent Office 1781261 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
McKinsey

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 verification 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.