Last Updated: September 24, 2026

AMANTADINE HYDROCHLORIDE - Generic Drug Details

Name: AMANTADINE HYDROCHLORIDE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 Zydus, Supernus Pharms, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Onesource, Rising, Rubicon Research, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Adaptis, Aurobindo Pharma Usa, Chartwell Rx, G And W Labs Inc, Ph Health, Pharm Assoc, Pharmobedient, Pom Pharma, Teva Pharms, Jubilant Generics, and Zhejiang Jutai Pharm, and is included in forty-two NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AMANTADINE HYDROCHLORIDE

International Patents:	49
US Patents:	21
Tradenames:	5
Applicants:	31
NDAs:	42
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	122
Patent Applications:	4,762
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
University of Texas Southwestern Medical Center	PHASE2
University Hospital, Toulouse	PHASE2
Ain Shams University	PHASE2

See all AMANTADINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for AMANTADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	EQ 68.5MG BASE	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 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	Strength	NDA	ANDAs Submitted	Submissiondate
GOCOVRI	Extended-release Capsules	amantadine hydrochloride	68.5 mg	208944	1	2020-04-30
GOCOVRI	Extended-release Capsules	amantadine hydrochloride	137 mg	208944	1	2018-01-16

US Patents and Regulatory Information for AMANTADINE 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
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Actavis Elizabeth	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	077659-001	Feb 23, 2006		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharm Assoc	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	SYRUP;ORAL	074509-001	Jul 17, 1995	AA	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start 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 AMANTADINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	⤷ Start Trial	⤷ Start Trial
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020	⤷ Start Trial	⤷ Start Trial
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	⤷ Start Trial	⤷ Start Trial
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	⤷ Start Trial	⤷ Start Trial
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for AMANTADINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014204933		⤷ Start Trial
Australia	2018320946		⤷ Start Trial
Australia	2024205201		⤷ Start Trial
Brazil	112020003375		⤷ Start Trial
Canada	3072764		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.