DrugPatentWatch Database Preview

NAMENDA XR Drug Profile

« Back to Dashboard

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:	3
Bulk Api Vendors:	83
Clinical Trials:	56
Patent Applications:	1,341
Formulation / Manufacturing:	see details
Drug Prices:	see details
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-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

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)

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

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

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	022525-001	Jun 21, 2010
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010
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	022525-003	Jun 21, 2010

Paragraph IV (Patent) Challenges for NAMENDA XR

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Capsules	7 mg, 14 mg, 21 mg, and 28 mg		2013-08-16
	Extended-release Capsules	7 mg, 14 mg, 21 mg		2013-06-17
	Extended-release Capsules	28 mg		2013-06-12
	Extended-release Capsules	7 mg, 14 mg, 21 mg, and 28 mg		2013-06-10

Non-Orange Book US Patents for NAMENDA XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,619,007	Method and composition for administering an NMDA receptor antagonist to a subject
8,058,291	Methods and compositions for the treatment of CNS-related conditions
8,293,794	Methods and compositions for the treatment of CNS-related conditions
2,012,045,508

International Patents for NAMENDA XR

Country	Document Number	Estimated Expiration
China	1929830
World Intellectual Property Organization (WIPO)	2006058059
Mexico	2007012374
Canada	2588295

Supplementary Protection Certificates for NAMENDA XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
02C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
C/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