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Baxter
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Covington
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Generated: October 19, 2018

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Memantine hydrochloride - Generic Drug Details

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What are the generic drug 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 Amneal Pharms, Anchen Pharms, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Sun Pharma Global, Zydus Pharms Usa Inc, Forest Labs Llc, Bio-pharm Inc, Lannett Co Inc, Macleods Pharms Ltd, Allergan Sales Llc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, Upsher-smith Labs, and Wockhardt Ltd, 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.

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

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-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 hy-drochloride
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
AK-44671
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
Ebixa
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-2015
Mantine
MCULE-6635165082
Memantin hydrochloride
Memantine (hydrochloride)
Memantine HCL
Memantine hydrochloride (JAN/USAN)
Memantine hydrochloride (Namenda)
Memantine hydrochloride [USAN]
memantine.HCl
Memantinehydrochloride
Memary
Memary (TN)
MFCD00214336
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
ST088119
SUN Y7017
SUN-Y7017
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
UNII-JY0WD0UA60
Z1551429722
Tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MGTABLET; ORAL
➤ Sign Up➤ Sign Up5MGTABLET; ORAL
➤ Sign Up➤ Sign Up10MGTABLET;ORAL

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
Mylan Pharms Inc MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206032-004 Sep 28, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Pharms Inc MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206032-002 Sep 28, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203293-002 Aug 3, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205825-003 Oct 12, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc NAMENDA memantine hydrochloride SOLUTION;ORAL 021627-001 Apr 18, 2005 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for memantine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02C/035 Belgium ➤ Sign Up PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
C/GB02/046 United Kingdom ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Accenture
McKesson
Express Scripts
Fish and Richardson
Moodys
Covington
Chinese Patent Office
Citi

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