NAMENDA XR Drug Patent Profile

Which patents cover Namenda Xr, and when can generic versions of Namenda Xr launch?

Namenda Xr is a drug marketed by Allergan and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in ten countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Namenda Xr

A generic version of NAMENDA XR was approved as memantine hydrochloride by DR REDDYS LABS LTD on April 14^th, 2010.

Summary for NAMENDA XR

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	73
Patent Applications:	2,688
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NAMENDA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAMENDA XR
DailyMed Link:	NAMENDA XR at DailyMed

See drug prices for NAMENDA XR

See drug sales revenues for NAMENDA XR

Recent Clinical Trials for NAMENDA XR

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
Children's Oncology Group	Phase 3
Mayo Clinic	Early Phase 1

See all NAMENDA XR clinical trials

Pharmacology for NAMENDA XR

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

Anatomical Therapeutic Chemical (ATC) Classes for NAMENDA XR

N06DX	Other anti-dementia drugs
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for NAMENDA XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMENDA XR	Extended-release Capsules	memantine hydrochloride	7 mg, 14 mg, 21 mg, and 28 mg	022525	1	2013-06-10

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
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	AB	RX	Yes	No					Y
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	AB	RX	Yes	Yes					Y
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-002	Jun 21, 2010	AB	RX	Yes	No					Y
Allergan	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
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010
Allergan	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-002	Jun 21, 2010

International Patents for NAMENDA XR

See the table below for patents covering NAMENDA XR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2554959	COMBINAISON D'ANTAGONISTE DE RECEPTEUR NMDA ET D'INHIBITEUR MAO OU GADPF POUR LE TRAITEMENT D'AFFECTIONS LIEES AU SYSTEME NERVEUX CENTRAL (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND A MAO-INHIBITOR OR A GADPF-INHIBITOR FOR THE TREATMENT OF CENTRAL NERVOUS SYSTEM-RELATED CONDITIONS)
Russian Federation	2007122410	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОСНОВУ ИЛИ ПОКРЫТИЕ ДЛЯ ЗАМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ И АНТАГОНИСТ NMDA-РЕЦЕПТОРА, СПОСОБ ВВЕДЕНИЯ ТАКОГО NMDA-АНТАГОНИСТА СУБЪЕКТУ
Israel	183384
Hungary	T58200
China	101247795	Methods and compositions for treatment of CNS disorders

Supplementary Protection Certificates for NAMENDA XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
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	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0392059	90988	Luxembourg