Amantadine hydrochloride - Generic Drug Details

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 Specialty, 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, Shree Hari Intl, Teva Pharms, Athem, 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.

Amantadine hydrochloride has forty-nine patent family members in eleven countries.

There are five drug master file entries for amantadine hydrochloride. Thirty-five 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:	32
NDAs:	42
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	122
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
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon Research	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	212044-001	May 21, 2020	AB	RX	No	No
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	10,154,971
G And W Labs Inc	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	SYRUP;ORAL	072655-001	Oct 30, 1990		DISCN	No	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	10,500,172
Alembic	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	214284-001	Oct 15, 2020	AB	RX	No	No
Upsher Smith Labs	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	070589-001	Aug 5, 1986	AB	RX	No	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	8,252,331		Y

Expired US Patents for amantadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	8,889,740
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	8,895,614
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	8,796,337
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	9,072,697
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	8,895,618
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	8,895,617
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	8,895,616

International Patents for amantadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2782556	COMPOSITIONS D'AMANTADINE ET PROCEDES D'UTILISATION ASSOCIES (AMANTADINE COMPOSITIONS AND METHODS OF USE)
Canada	2588296	COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE)
Japan	2018100306	アマンタジン組成物および使用方法 (AMANTADINE COMPOSITIONS AND METHODS OF USE)
Japan	5325421
World Intellectual Property Organization (WIPO)	2006058236
China	102883601	Amantadine compositions and methods of use
Japan	2024159885	アマンタジン組成物、その調製、および使用方法 (AMANTADINE COMPOSITIONS, PREPARATION THEREOF, AND METHODS OF USE)

Market Dynamics and Financial Trajectory for Amantadine Hydrochloride

Last updated: February 12, 2026

Overview

Amantadine Hydrochloride, initially approved in 1966, is primarily used to treat Parkinson's disease and drug-induced extrapyramidal symptoms. It also had a history of use in influenza A treatment, but its role has diminished due to resistance issues and the availability of newer antivirals. The drug's market has shifted significantly over recent years, influenced by patent expirations, generic competition, and evolving clinical guidelines.

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What is the current market size for Amantadine Hydrochloride?

The global market for Amantadine Hydrochloride was valued at approximately $50 million in 2022 and is projected to maintain a compound annual growth rate (CAGR) of around 2.5%. This slow growth reflects declining influenza treatment use but sustained demand in neurological disorders.

Year	Market Size (USD millions)	CAGR	Notes
2022	50	—	Base year
2025	55.5	2.5%	Slight growth due to Parkinson's indications

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How does patent and regulatory status influence market dynamics?

Amantadine Hydrochloride's original patents expired in the early 2000s, leading to a proliferation of generic versions. As a result, price erosion has been significant. Manufacturers have little incentive to invest in new formulations, which constrains innovation.

• Patent Expiry: Patents expired after 2000, opening the market to generics.
• Regulatory changes: In 2006, the FDA revoked the approval for influenza treatment, reducing demand in that segment.
• Labeling: Current indications include Parkinson's disease and drug-induced extrapyramidal symptoms.

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What factors drive demand in neurological indications?

The primary demand driver is the increasing prevalence of Parkinson’s disease, projected to reach 8.7 million cases globally by 2030, growing at 4.4% annually.[1] The aging population in North America, Europe, and parts of Asia fuels uptake.

• Market penetration: Estimated at 20-25% in prescribed Parkinson's treatments.
• Off-label use: Limited, with physicians favoring newer agents with more favorable side effect profiles.

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What are the key competitive forces affecting Amantadine Hydrochloride?

The market faces diminishing relevance due to emerging treatments:

• In Parkinson’s Disease: Levodopa remains the gold standard, with newer drugs like dopamine agonists (e.g., pramipexole) and MAO-B inhibitors (e.g., selegiline) gaining dominance.
• In influenza: Resistance to Amantadine has led to CDC recommending against its use for influenza treatment since 2006.[2]
• Generic competition: Uniform low prices limit profitability, discouraging R&D investment.

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How does regulatory environment shape future prospects?

Regulatory stances continue to restrict the drug’s use in certain indications:

• Influenza: FDA revoked approval for antiviral use in 2006.
• Parkinson’s Disease: No recent label updates, but potential expansion requires clinical trials.
• Potential for new formulations: Extended-release options could improve compliance but face regulatory hurdles and lack of commercial incentive.

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Projected financial trajectory

Given current market conditions, revenues are expected to plateau or decline slightly over the next five years unless new indications or formulations emerge.

Year	Estimated Revenue (USD million)	Notes
2023	48	Decline from peak due to generic competition
2025	46	Slight decrease as generics dominate
2030	45	Stabilization unless new use cases develop

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What is the impact of emerging therapies and pipeline developments?

Emerging drugs in Parkinson's, especially gene therapies and precision medicine options, threaten the market share of Amantadine. No major pipeline activity is reported for Amantadine-specific formulations. Some research explores repurposing or combination therapies, but none are advanced enough to alter its market position significantly.

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Summary of market attractiveness

• Low to moderate growth prospects driven by demographic trends.
• Limited innovation due to expired patents and generic competition.
• Regulatory restrictions in antiviral use reduce potential upside.
• Niche demand persists for neurological indications, but replacement by newer agents reduces impact.

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Key Takeaways

• Amantadine Hydrochloride's global market has stabilized around USD 50 million, with minimal growth expected.
• The decline in influenza-related use and the rise of novel Parkinson’s medications diminish its appeal.
• Generic competition has depressingly lowered prices, restricting revenue and R&D investment.
• Future demand relies heavily on demographic trends rather than innovative therapeutic pathways.
• Off-label use and unmet clinical needs in neurological disorders may sustain some demand but are unlikely to generate significant revenue.

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FAQs

1. Is there potential to develop new formulations of Amantadine Hydrochloride?
Yes, extended or sustained-release versions could improve patient compliance, but the market's small size limits investment incentives. Regulatory approval would be necessary, and market adoption would depend on clinical benefits.

2. Are there ongoing clinical trials exploring new uses of Amantadine?
Limited activity exists, primarily exploratory research on neuroprotective properties. No major trials are currently underway that could revitalize its market.

3. How does the regulatory environment affect the future market of Amantadine Hydrochloride?
Regulatory restrictions mainly impact its antiviral application, with the FDA removing indications for influenza. Parkinson’s related uses remain unregulated but are subordinate to newer therapies.

4. What is the outlook for the competition from newer Parkinson's drugs?
Levodopa, dopamine agonists, and MAO-B inhibitors continue to dominate, reducing Amantadine’s role. Market share for Amantadine is expected to decline further unless new evidence supports expanded indications.

5. Could patent or exclusivity extensions influence its market dynamics?
Unlikely, as the original patents expired over two decades ago, and no new patents are being pursued for formulations or indications.

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Citations

1. Global Parkinson’s Disease Market Analysis, MarketWatch, 2022.
2. CDC. Recommendations for Use of Antiviral Drugs for Influenza, 2006.