MEMANTINE HYDROCHLORIDE - Generic Drug Details

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, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Abbvie, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Allergan, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-five NDAs. There is one patent protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Memantine hydrochloride has ten patent family members in nine countries.

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

Summary for MEMANTINE HYDROCHLORIDE

International Patents:	10
US Patents:	1
Tradenames:	3
Applicants:	37
NDAs:	45
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	243
Patent Applications:	4,101
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEMANTINE HYDROCHLORIDE
What excipients (inactive ingredients) are in MEMANTINE HYDROCHLORIDE?	MEMANTINE HYDROCHLORIDE excipients list
DailyMed Link:	MEMANTINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MEMANTINE HYDROCHLORIDE

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

Sponsor	Phase
NeuroSense Therapeutics Ltd.	Phase 2
Mansoura University	Phase 1/Phase 2
Simon Ducharme, MD	Phase 3

See all MEMANTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		28MG	CAPSULE, EXTENDED RELEASE;ORAL
		21MG	CAPSULE, EXTENDED RELEASE;ORAL
		14MG	CAPSULE, EXTENDED RELEASE;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

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

Medical Subject Heading (MeSH) Categories for MEMANTINE HYDROCHLORIDE

Antiparkinson Agents

Dopamine Agents

Excitatory Amino Acid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MEMANTINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for MEMANTINE HYDROCHLORIDE

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
NAMENDA	Tablets	memantine hydrochloride	5 mg and 10 mg	021487	14	2007-10-16

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
Yichang Humanwell	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211100-001	Apr 2, 2021	AB	RX	No	No
Dr Reddys Labs Ltd	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090048-002	Apr 14, 2010	AB	RX	No	No
Ajanta Pharma Ltd	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	206528-002	Nov 30, 2015	AB	RX	No	No

Expired US Patents for MEMANTINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003

EU/EMA Drug Approvals for MEMANTINE HYDROCHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merz Pharmaceuticals GmbH	Memantine Merz	memantine hydrochloride	EMEA/H/C/002711 Treatment of patients with moderate to severe Alzheimer’s disease.	Authorised	no	no	no	2012-11-22

International Patents for MEMANTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1781261	FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE)
Australia	2005265031	Modified release formulation of memantine
Eurasian Patent Organization	011446	ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (PREPARATORY SOLID ORAL DOSAGE FORM OF MEMANTINE WITH MODIFIED RELEASE)

Supplementary Protection Certificates for MEMANTINE HYDROCHLORIDE

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