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Last Updated: October 20, 2019

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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 patent protection?

Memantine hydrochloride is the generic ingredient in three branded drugs marketed by Amneal Pharms, Anchen Pharms, Apotex Inc, Lupin Ltd, Mylan, Sun Pharm, Zydus Pharms, Forest Labs Llc, Lannett Co Inc, Macleods Pharms Ltd, Torrent, Allergan Sales Llc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Celltrion, Cspc Ouyi, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Unichem Labs Ltd, and Upsher Smith Labs, and is included in thirty-six NDAs. There are seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Memantine hydrochloride has sixty-nine patent family members in nineteen countries.

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

Recent Clinical Trials for memantine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
University of North Carolina, Chapel HillPhase 2
Ministry of Science and Technology, TaiwanPhase 2/Phase 3

See all memantine hydrochloride clinical trials

Recent Litigation for memantine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Allergan Sales LLC v. Macleods Pharmaceuticals, Ltd.2017-06-02
Forest Laboratories, LLC v. Macleods Pharmaceuticals, Ltd.2017-06-02

See all memantine hydrochloride litigation

PTAB Litigation
PetitionerDate
Ranbaxy, Inc.2014-12-18

See all memantine hydrochloride litigation

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET; ORAL
  Start Trial  Start Trial5MGTABLET; ORAL
  Start Trial  Start Trial5MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for memantine hydrochloride
Medical Subject Heading (MeSH) Categories for memantine hydrochloride
Synonyms for memantine hydrochloride
(3,5-Dimethyl-1-adamantyl)amine hydrochloride
1-amino-3,5-dimethyl-adamantane hydrochloride
1-Amino-3,5-dimethyladamantane Hydrochloride
1,3-Dimethyl-5-aminoadamantane hydrochloride, 99%
1,3-Dimethylaminoadamantane hydrochloride
19982-08-2 (Parent)
3,5-Dimethyl-1-adamantanamine hydrochloride
3,5-Dimethyl-1-adamantanamineHydrochloride
3,5-Dimethyl-1-aminoadamantane HCl
3,5-Dimethyl-1-aminoadamantane hydrochloride
3,5-Dimethyl-tricyclo[3.3.1.13,7]decan-1-amine hydrochloride
3,5-DIMETHYLADAMANTAN-1-AMINE HCL
3,5-dimethyladamantan-1-amine hy-drochloride
3,5-dimethyladamantan-1-amine hydrochloride
3,5-dimethyladamantan-1-amine;hydrochloride
3,5-dimethyladamantan-1-amine;hydrochloride.
3,5-dimethyladamantan-1-aminium chloride
3,5-dimethyladamantanylamine, chloride
3,5-Dimethylamantadine hydrochloride
3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine hydrochloride
3,5-Dimethyltricyclo(3.3.1.1(sup 3,7))decan-1-amine hydrochloride
3,5-Dimethyltricyclo(3.3.1.13,7)decan-1-amine hydrochloride
3,5-dimethyltricyclo[3.3.1.13,7]decan-1-amine hydrochloride
41100-52-1
4CH-006120
AB0013351
AB2000447
AC-559
AC1L492E
ACMC-209jif
Akatinol
AKOS015889460
AM20070534
AN-15700
ANW-29557
AOB5318
AS-13331
AX8033628
Axura
BC208848
BCP9000253
BG0374
BR-44671
CCG-39018
CHEBI:64323
CHEMBL1699
CPD000058926
CPD000875213
CS-2422
CTK8B1656
D 145
D-145
D04905
D3608
Ebixza
EINECS 255-219-6
EU-0100861
FT-0650723
H908
HMS1571C17
HMS1921H03
HY-B0365A
I01-2072
J10287
JY0WD0UA60
KS-00000X1M
KSC911M5N
LDDHMLJTFXJGPI-UHFFFAOYSA-N
LP00861
M 9292
M-145
M-2015
Mantine
MCULE-6635165082
Memantin hydrochloride
Memantine (hydrochloride)
Memantine HCL
Memantine hydrochloride (JAN/USAN)
Memantine hydrochloride (Namenda)
Memantine hydrochloride [USAN]
memantine.HCl
Memary
Memary (TN)
MFCD00214336
MFCD00214336 (97%)
MLS001332605
MLS001332606
MolPort-003-666-358
MRZ-2/145
N06DX01
Namenda
Namenda (TN)
Namenda XR
NC00680
NCGC00094186-01
NCGC00094186-02
NCGC00094186-03
NCGC00261546-01
NMI-131
NSC 102290
NSC-102290
NSC-757843
NSC102290
NSC757843
Pharmakon1600-01501121
RTR-016345
s2043
SAM001246743
SAM002699890
SBB003390
SCHEMBL3053
SMR000875213
SPECTRUM1501121
SR-01000075458
SR-01000075458-1
SR-01000075458-3
SR-01000075458-8
ST088119
SUN Y7017
SUN-Y7017
SW060653-4
SY057917
Tox21_500861
TR-016345
Tricyclo(3.3.1.1(3,7))decan-1-amine, 3,5-dimethyl-, hydrochloride
Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, 3,5-dimethyl-, hydrochloride
Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, hydrochloride
UNII-JY0WD0UA60
Z1551429722

US Patents and Regulatory Information for memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206028-003 Sep 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090052-002 Oct 25, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc NAMENDA memantine hydrochloride TABLET;ORAL 021487-001 Oct 16, 2003   Start Trial   Start Trial
Allergan Sales Llc NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for memantine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 SPC/GB02/046 United Kingdom   Start Trial PRODUCT 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
0392059 2002C/035 Belgium   Start Trial PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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