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Memantine hydrochloride - Generic Drug Details

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Memantine hydrochloride is the generic ingredient in three branded drugs marketed by Sun Pharma Global, Unichem Labs Ltd, Amneal Pharms, Forest Labs Llc, Mylan Pharms Inc, Lupin Ltd, Ajanta Pharma Ltd, Silarx Pharms Inc, Apotex Inc, Macleods Pharms Ltd, Upsher-smith Labs, Orchid Hlthcare, Bio-pharm Inc, Dr Reddys Labs Ltd, Teva Pharms, Puracap Pharm Llc, Torrent Pharms Ltd, Wockhardt Ltd, Aurobindo Pharma Ltd, Jubilant Generics, and Alembic Pharms Ltd, and is included in twenty-nine NDAs. There are eight patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-one patent family members in fifteen countries.

There are twenty-eight drug master file entries for memantine hydrochloride. Thirty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: memantine hydrochloride

Tradenames:3
Patents:8
Applicants:21
NDAs:29
Drug Master File Entries: see list28
Suppliers / Packagers: see list35
Bulk Api Vendors: see list69
Clinical Trials: see list1,068
Patent Applications: see list1,165
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: memantine hydrochloride

Tentative approvals for MEMANTINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL5MG
<disabled><disabled>TABLET; ORAL10MG
<disabled><disabled>TABLET;ORAL5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-002Jun 21, 2010RXNo8,329,752*PED► subscribeY► subscribe
Lupin Ltd
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
TABLET;ORAL090051-002Apr 10, 2015RXNo► subscribe► subscribe
Macleods Pharms Ltd
MEMANTINE HYDROCHLORIDE
memantine hydrochloride
SOLUTION;ORAL202790-001Oct 13, 2015RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 20105,061,703*PED► subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 20055,614,560► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 20105,061,703*PED► subscribe
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International Patent Family for Ingredient: memantine hydrochloride

Country Document Number Estimated Expiration
Portugal93763► subscribe
Japan2821233► subscribe
Spain2059602► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MEMANTINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02C/035Belgium► subscribePRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
C/GB02/046United Kingdom► subscribePRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515
90025-6Sweden► subscribePRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
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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.

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