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 thirty-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:	31
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
Upsher Smith Labs	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	070589-001	Aug 5, 1986	AB	RX	No	No
Rubicon Research	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	212044-001	May 21, 2020	AB	RX	No	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No

Expired US Patents for AMANTADINE HYDROCHLORIDE

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

International Patents for AMANTADINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2012006320
Japan	5885668
Japan	2015131818
Mexico	2012006320	COMPOSICIONES DE AMANTADINA Y METODOS PARA SU USO. (AMANTADINE COMPOSITIONS AND METHODS OF USE.)
Japan	2020531543	アマンタジン組成物、その調製、および使用方法

Market Dynamics and Financial Trajectory for Amantadine Hydrochloride

Last updated: July 27, 2025

Overview of Amantadine Hydrochloride

Amantadine hydrochloride is an established antiviral and antiparkinsonian agent originally approved in the 1960s. Primarily used for Parkinson’s disease and drug-induced extrapyramidal symptoms, it also has antiviral activity against influenza A viruses. Despite its long history, the drug’s market presence has shifted significantly over recent years due to evolving medical guidelines, patent landscapes, and competition from newer therapeutics.

Current Market Landscape

Therapeutic Applications and Demand Drivers

Amantadine hydrochloride’s primary indications remain Parkinson’s disease management and prevention of influenza A, although latter has seen diminished use due to widespread vaccination and antiviral resistance. In Parkinson’s therapy, amantadine offers symptomatic relief, especially in early-stage disease, acting as a dopaminergic agent and mitigating dyskinesias caused by levodopa therapy. Its antiviral use has declined sharply following the emergence of resistance and alternative antivirals like oseltamivir.

The mature therapeutic domains limit growth potential, but the drug retains niche appeal in specific patient populations, particularly where newer therapies are contraindicated or less tolerated. Market demand hinges on the prevalence of Parkinson’s disease, which is projected to grow with an aging global population—estimated to reach approximately 125 million by 2040 per WHO forecasts[1].

Regulatory and Patent Status

Amantadine hydrochloride's patent exclusivity has long expired, rendering generic versions widespread. The absence of patent protection constrains opportunities for branded sales, compelling pharmaceutical companies to compete mainly on price and supply reliability. However, some formulations, such as extended-release versions, may hold patent protections, offering niche commercialization prospects.

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Market Dynamics

Competitive Environment

The competitive landscape for amantadine is heavily influenced by generic end users and off-label prescribing trends. The entry of newer, more selective Parkinson’s drugs—like dopamine agonists, MAO-B inhibitors, and COMT inhibitors—has reduced the drug’s market share. Nonetheless, amantadine remains prescribed off-label for dyskinesia management and as an adjunct, maintaining a baseline demand in specialized neurology settings.

Additionally, the availability of combination therapy formulations and off-patent status fosters price competition, which can depress margins for manufacturers. Companies may also leverage niche formulations or specialized licensing to sustain revenue streams.

Market Challenges

Key challenges include:

• Resistance and Reduced Efficacy in Antiviral Use: The rise of antiviral resistance in influenza A strains has diminished amantadine’s antiviral role, relegating it to a limited scope.

• Shift Toward Newer Therapies: Innovation in Parkinson’s disease management leads to decreased reliance on amantadine, especially with drugs demonstrating better safety profiles and efficacy.

• Regulatory and Safety Concerns: Reports of neuropsychiatric side effects have led to cautious prescribing, influencing market dynamics negatively.

Emerging Opportunities

Despite challenges, certain niches remain promising:

• Extended-Release Formulations: Marketed via patents, these offer enhanced patient compliance and clinical differentiation [2].
• Combination Therapies: Potential for formulation with other Parkinson’s drugs could carve out specific market segments.
• Off-Label Uses: Persistent off-label prescribing in movement disorders sustains underlying demand.

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Financial Trajectory Predictions

Revenue Trends

Given the broader decline in antiviral use, revenues from amantadine are primarily driven by Parkinson’s management. Analyses indicate a gradual decline in global sales over the past decade, with annual revenues estimated around $200 million–$300 million worldwide—declining by roughly 3-5% annually[3].

Branded sales, limited due to extensive generics, are largely confined to formulations with patent protection—such as extended-release versions, which may sustain higher margins. However, their market share remains modest relative to generics.

Market Forecast (Next 5-10 Years)

Forecasts project future revenues to decline further, possibly stabilizing at a niche level, unless new formulations or indications emerge:

• Global Parkinson’s population and increased disease awareness might sustain modest volume, but pricing pressure will persist.
• Emerging markets could present growth avenues due to rising healthcare infrastructure, especially if local generics are introduced.
• Regulatory Environment: Stricter safety monitoring could impact prescribing patterns, further constraining revenues.

Overall, the financial trajectory for amantadine hydrochloride remains cautious, with a declining trend driven by competitive, clinical, and resistance challenges.

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Market Strategies and Outlook

Pharmaceutical companies aiming to capitalize on amantadine’s prospects should consider:

• Product differentiation via extended-release formulations.
• Targeted marketing toward neurology specialists.
• Strategic licensing for niche formulations.
• Exploring new indications, such as potential neuroprotective properties, although current evidence remains limited.

Investors should remain wary of declining revenues but identify potential upside in specialty formulations and emerging markets.

Key Takeaways

• Limited Growth Prospects: Amantadine hydrochloride faces a stable but declining market due to competition and resistance issues.
• Niche Markets Remain Viable: Extended-release formulations and off-label uses sustain segments of demand.
• Generic Competition Dominates: Patent expiration has resulted in widespread generics, suppressing pricing power.
• Emerging Opportunities: Specialized formulations and unexplored indications may offer incremental growth.
• Strategic Focus Needed: Companies should leverage differentiation and targeted marketing strategies to sustain revenues.

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FAQs

1. What are the primary therapeutic uses of amantadine hydrochloride today?
Amantadine is chiefly used to manage Parkinson’s disease symptoms and as prophylaxis or treatment for influenza A (though the latter use has declined globally).

2. How has generic competition affected amantadine’s market value?
Widespread availability of generics has drastically lowered prices and limited revenue potential for branded versions, constraining growth.

3. Are there new formulations of amantadine that could revitalize its market?
Yes, extended-release formulations are protected by patents and offer improved compliance, representing niche opportunities for differentiation.

4. What factors are likely to influence its long-term market performance?
Key factors include the aging population, evolving treatment paradigms in Parkinson’s disease, resistance issues in antiviral use, and regulatory safety concerns.

5. Is there potential for amantadine to be repurposed for new indications?
Research into neuroprotective and cognitive applications is ongoing but remains preliminary; any promising development could alter its market trajectory.

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References

[1] World Health Organization. “Dementia and Parkinson’s Disease: Global Burden and Trends,” 2022.
[2] PharmaNews. “Extended-Release Amantadine: Market Prospects and Patent Landscape,” 2021.
[3] IMS Health. “Global Antiparkinsonian Drug Market Report,” 2022.