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NAMENDA XR Drug Profile

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Which patents cover Namenda Xr, and what generic alternatives are available?

Namenda Xr is a drug marketed by Forest Labs Llc and is included in one NDA. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has sixty-nine patent family members in nineteen countries.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for NAMENDA XR

International Patents:	69
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	93
Clinical Trials:	58
Patent Applications:	1,399
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NAMENDA XR
Drug Sales Revenues:	Drug sales revenues for NAMENDA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAMENDA XR
DailyMed Link:	NAMENDA XR at DailyMed

Pharmacology for NAMENDA XR

Drug Class	N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for NAMENDA XR

Antiparkinson Agents

Dopamine Agents

Excitatory Amino Acid Antagonists

Synonyms for NAMENDA XR

(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

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)

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 NAMENDA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	AB	RX	Yes	Yes					Y
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	AB	RX	Yes	Yes
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	AB	RX	Yes	No					Y
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010	AB	RX	Yes	No					Y
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	AB	RX	Yes	Yes					Y
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	AB	RX	Yes	No

Expired US Patents for NAMENDA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-002	Jun 21, 2010
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010

Paragraph IV (Patent) Challenges for NAMENDA XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Capsules	7 mg, 14 mg, 21 mg
	Extended-release Capsules	28 mg
	Extended-release Capsules	7 mg, 14 mg, 21 mg, and 28 mg
	Extended-release Capsules	7 mg, 14 mg, 21 mg, and 28 mg

International Patents for NAMENDA XR

Country	Patent Number	Estimated Expiration
Mexico	2007006120
Canada	2556216
Hong Kong	1103517
Japan	2007522249
European Patent Office	1827385
Eurasian Patent Organization	011446

Supplementary Protection Certificates for NAMENDA XR

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