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Amantadine hydrochloride - Generic Drug Details

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What are the generic drug sources for amantadine hydrochloride and what is the scope of freedom to operate?

Amantadine hydrochloride is the generic ingredient in five branded drugs marketed by Adamas Pharma, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Invagen Pharms, Lannett Co Inc, Novelgenix Theraps, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Akorn, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, and Jubilant Generics, and is included in thirty-six NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has thirty-four patent family members in ten countries.

There are seven drug master file entries for amantadine hydrochloride. Twenty-nine suppliers are listed for this compound.

Summary for amantadine hydrochloride

International Patents:	34
US Patents:	27
Tradenames:	5
Applicants:	26
NDAs:	36
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	108
Patent Applications:	2,566
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amantadine hydrochloride
What excipients (inactive ingredients) are in amantadine hydrochloride?	amantadine hydrochloride excipients list
DailyMed Link:	amantadine hydrochloride at DailyMed

Recent Clinical Trials for amantadine hydrochloride

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

Sponsor	Phase
Indian Council of Medical Research	Phase 4
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Copenhagen University Hospital, Hvidovre	Phase 3

See all amantadine hydrochloride clinical trials

Pharmacology for amantadine hydrochloride

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for amantadine hydrochloride

Analgesics, Non-Narcotic

Antiparkinson Agents

Antiviral Agents

Dopamine Agents

Anatomical Therapeutic Chemical (ATC) Classes for amantadine hydrochloride

N04BB	Adamantane derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for AMANTADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
GOCOVRI	CAPSULE, EXTENDED RELEASE;ORAL	amantadine hydrochloride	208944	2020-04-30
GOCOVRI	CAPSULE, EXTENDED RELEASE;ORAL	amantadine hydrochloride	208944	2018-01-16

US Patents and Regulatory Information for amantadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No			Y
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No			Y
Adamas Pharma	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No
Adamas Pharma	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes

Expired US Patents for amantadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018

International Patents for amantadine hydrochloride

Country	Patent Number	Estimated Expiration
China	106389381
World Intellectual Property Organization (WIPO)	2011069010
Japan	5885668
Spain	2549581
European Patent Office	1834638