MEMANTINE HYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

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-one 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:	41
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
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
⤷ Sign Up	⤷ Sign Up	28MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	21MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orbion Pharms	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090044-002	Mar 12, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Puracap Pharm Llc	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	206855-002	Nov 17, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	207236-001	Nov 10, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	⤷ Sign Up	⤷ Sign Up
Allergan	NAMENDA	memantine hydrochloride	SOLUTION;ORAL	021627-001	Apr 18, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for MEMANTINE HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	1968684	Modified release formulation of memantine	⤷ Sign Up
Mexico	PA06014587	FORMULACIONES DE LIBERACION MODIFICADA DE FORMULACIONES DE DOSIFICACION ORAL DE MEMANTINA. (MODIFIED RELEASE FORMULATION OF MEMANTINE.)	⤷ Sign Up
Eurasian Patent Organization	200700049	ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MEMANTINE HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0392059	2002C/035	Belgium	⤷ Sign Up	PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059	SPC/GB02/046	United Kingdom	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.