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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. There have been zero Paragraph IV challenges on Namzaric and Namenda XR There are two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

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 Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Forest Labs Llc
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 2010RXYesNo8,039,009*PED► SubscribeY
Forest Labs Llc
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-002Jun 21, 2010RXYesNo8,039,009*PED► SubscribeY
Forest Labs Llc
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010RXYesNo8,039,009*PED► SubscribeY
Forest Labs Llc
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYesYes8,039,009*PED► SubscribeY
Forest Labs Llc
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXYesNo8,039,009*PED► SubscribeY
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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.