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Last Updated: April 19, 2024

Memantine hydrochloride - Generic Drug Details

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What are the generic drug 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, Anchen Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Abbvie, Apozeal Pharms, Chartwell Molecular, Macleods Pharms Ltd, Seton Pharms, Allergan, Ajanta Pharma Ltd, Alembic, Celltrion, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Renata, 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:	242
Patent Applications:	4,247
Formulation / Manufacturing:	see details
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
Mansoura University	Phase 1/Phase 2
Alzheimer's Drug Discovery Foundation	Phase 3
University of Chicago	Phase 2/Phase 3

See all memantine hydrochloride clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	28MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	21MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205365-003	Feb 28, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	200891-002	Oct 13, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Lifesciences	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090961-001	Jul 10, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	079225-002	Jan 30, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Yichang Humanwell	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211100-002	Apr 2, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	203175-002	Oct 13, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for memantine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Allergan	NAMENDA	memantine hydrochloride	SOLUTION;ORAL	021627-001	Apr 18, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	⤷ Try a Trial	⤷ Try a Trial
Allergan	NAMENDA	memantine hydrochloride	SOLUTION;ORAL	021627-001	Apr 18, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for memantine hydrochloride

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for memantine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	011446	ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (PREPARATORY SOLID ORAL DOSAGE FORM OF MEMANTINE WITH MODIFIED RELEASE)	⤷ Try a Trial
Australia	2005265031	Modified release formulation of memantine	⤷ Try a Trial
Canada	2569015	FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE)	⤷ Try a Trial
Mexico	PA06014587	FORMULACIONES DE LIBERACION MODIFICADA DE FORMULACIONES DE DOSIFICACION ORAL DE MEMANTINA. (MODIFIED RELEASE FORMULATION OF MEMANTINE.)	⤷ Try a Trial
China	1968684	Modified release formulation of memantine	⤷ Try a Trial
European Patent Office	1781261	FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE)	⤷ Try a Trial
Eurasian Patent Organization	200700049	ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for memantine hydrochloride

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

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