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Generated: May 22, 2017

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Memantine hydrochloride - Generic Drug Details

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What are the generic sources for memantine hydrochloride and what is the scope of memantine hydrochloride patent protection?

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.

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

Summary for Generic Name: memantine hydrochloride

Drug Master File Entries: see list28
Suppliers / Packagers: see list36
Bulk Api Vendors: see list69
Clinical Trials: see list1,070
Patent Applications: see list1,926
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:memantine hydrochloride at DailyMed

Pharmacology for Ingredient: memantine hydrochloride

Tentative approvals for MEMANTINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MGTABLET; ORAL
► Subscribe► Subscribe10MGTABLET; ORAL
► Subscribe► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Silarx Pharms Inc
memantine hydrochloride
TABLET;ORAL207236-001Nov 10, 2016ABRXNoNo► Subscribe► Subscribe
Forest Labs Llc
memantine hydrochloride
TABLET;ORAL021487-001Oct 16, 2003ABRXYesNo► Subscribe► Subscribe
Forest Labs Llc
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 2010ABRXYesNo8,168,209*PED► SubscribeY► Subscribe
Jubilant Generics
memantine hydrochloride
TABLET;ORAL091585-001Oct 13, 2015ABRXNoNo► Subscribe► Subscribe
Amneal Pharms
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205825-003Oct 12, 2016ABRXNoNo► Subscribe► Subscribe
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  • Formulary management
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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