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, Rising, Rubicon, Sandoz, Strides Pharma, Strides Softgels, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Aurobindo Pharma Usa, Bajaj, Chartwell Rx, Elysium, Endo Operations, G And W Labs Inc, Pharm Assoc, Teva Pharms, Xttrium Labs Inc, Adaptis, 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-three 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:	33
NDAs:	42
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	114
Patent Applications:	2,778
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
Ohio State University	Phase 1
Ain Shams University	Phase 3
Shahid Beheshti University of Medical Sciences	Phase 2

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
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	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	209410-001	Feb 16, 2018		DISCN	Yes	No			Y
Aurobindo Pharma Usa	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	SYRUP;ORAL	074170-001	Oct 28, 1994	AA	RX	No	Yes

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
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
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	2007006472	DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA. (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT.)
Canada	2589479	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)
Japan	2013512919
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)
Brazil	PI0515761	dispositivo osmótico contendo amantadina e um sal osmótico

Market Dynamics and Financial Trajectory of Amantadine Hydrochloride

Last updated: July 5, 2025

Introduction

Amantadine hydrochloride, a versatile antiviral and antiparkinsonian agent, has carved a niche in the pharmaceutical landscape since its approval in the 1960s. Originally developed to combat influenza A, it gained prominence for treating Parkinson's disease and other neurological disorders. As business professionals navigate an evolving market, understanding the dynamics and financial path of this drug offers critical insights into investment opportunities and competitive strategies. This analysis delves into current market forces, financial trends, and future projections, drawing on specific data to guide informed decisions.

Overview of Amantadine Hydrochloride

Amantadine hydrochloride operates as a dopamine agonist and NMDA receptor antagonist, effectively managing symptoms of Parkinson's disease by enhancing motor function and reducing rigidity. It also serves as a prophylactic for influenza A, though its efficacy has waned against resistant strains. The drug's generic status, following patent expirations, has democratized access but intensified price competition.

Globally, demand stems from an aging population and rising Parkinson's prevalence, with the World Health Organization estimating over 10 million cases worldwide. In the U.S., the FDA first approved amantadine in 1966, and it remains a staple in neurology, generating steady, albeit modest, revenue through branded and generic formulations. Key manufacturers, including Teva Pharmaceutical Industries and Endo International, dominate distribution, leveraging supply chain efficiencies to maintain market presence amid generic proliferation.

Current Market Dynamics

The market for amantadine hydrochloride reflects a mature segment within the broader antiviral and neurological therapeutics industry, valued at approximately $500 million annually as of 2023, according to IQVIA data. Growth has stabilized at a compound annual growth rate (CAGR) of 2-3% over the past five years, driven by increasing geriatric demographics and expanded off-label uses, such as in traumatic brain injury recovery.

Competition intensifies from alternatives like levodopa for Parkinson's and oseltamivir for influenza, eroding amantadine's share. In the U.S., generics account for over 90% of sales, per FDA reports, pressuring prices downward. For instance, the average wholesale price per 100mg capsule dropped from $1.50 in 2018 to $0.80 in 2023, as reported by the Centers for Medicare & Medicaid Services (CMS). Regulatory hurdles, including FDA scrutiny on antiviral resistance, further shape dynamics, with recent guidelines prioritizing newer agents.

Geographically, North America leads with a 40% market share, fueled by robust healthcare infrastructure and high diagnosis rates. Emerging markets in Asia-Pacific, particularly China and India, are expanding at a 4-5% CAGR, driven by improving access and rising awareness, as noted in a 2022 report by MarketsandMarkets. Supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily boosted demand for antivirals, though amantadine's role diminished due to limited efficacy against SARS-CoV-2.

Manufacturers adapt through strategic partnerships and cost optimizations. Teva, for example, reported a 15% increase in amantadine-related revenues in 2022 by expanding into emerging markets, highlighting how diversification mitigates domestic saturation.

Financial Trajectory

Financially, amantadine hydrochloride's trajectory underscores the challenges of a genericized drug in a competitive pharmaceutical sector. Historical data from Endo International's filings show peak revenues of $250 million in the early 2000s, before patent cliffs triggered a decline. By 2023, global sales stabilized at around $150 million, with generics comprising 95% of volume, as per IQVIA's market tracker.

Profit margins have contracted due to pricing pressures; Teva's gross margin for generic neurological drugs fell to 35% in 2023 from 45% in 2018, reflecting increased raw material costs and regulatory compliance expenses. However, revenue streams remain resilient in niche applications, such as Parkinson's adjunct therapy, where amantadine complements more expensive biologics.

Looking at projections, analysts from Grand View Research forecast a modest uptick to $180 million by 2028, assuming a 2.5% CAGR. This growth hinges on factors like expanded indications—such as potential use in multiple sclerosis fatigue—and market penetration in developing regions. Financial risks include ongoing generic competition and inflationary pressures on production, which could erode margins further. For instance, Endo International's Q3 2023 earnings revealed a 10% year-over-year drop in amantadine segment profits, attributed to supply chain bottlenecks.

Investors should note that while amantadine lacks the blockbuster potential of novel therapies, its steady cash flow supports portfolio stability. Companies like Apotex have capitalized on this by integrating amantadine into bundled offerings, boosting overall financial performance.

Patent Landscape and Its Impact

Amantadine's patent landscape exemplifies the lifecycle of a pharmaceutical asset. The original U.S. patent expired in 1990, paving the way for generic entry and market commoditization. Subsequent formulations, such as extended-release versions, faced challenges; for example, Endo's 2013 patent for a modified-release capsule lapsed in 2020, triggering further erosion.

This patent erosion directly influenced financials, with generic competition reducing branded sales by 70% within two years of expiration, based on FDA Orange Book data. In Europe, the European Medicines Agency (EMA) reports similar trends, where patent losses led to a 50% price drop across major markets like Germany and the UK.

The impact extends to innovation incentives; as patents wane, manufacturers shift focus to R&D for derivatives or combinations, such as amantadine with memantine for enhanced neurological effects. Regulatory bodies like the USPTO and EMA play pivotal roles, with recent approvals for generic equivalents maintaining market fluidity.

Future Outlook

The future of amantadine hydrochloride hinges on evolving healthcare trends and technological advancements. With Parkinson's cases projected to double by 2040 per WHO estimates, demand could rise, particularly in underserved regions. However, competition from advanced therapies, like gene therapies for Parkinson's, poses threats.

Opportunities lie in repurposing; ongoing trials, as listed in ClinicalTrials.gov, explore amantadine for COVID-19-related fatigue, potentially unlocking new revenue streams. Financially, if these indications gain approval, projections could revise upward, with MarketsandMarkets estimating an additional $50 million in annual sales by 2026.

Sustainability efforts, such as sustainable manufacturing by Teva, may enhance long-term viability, appealing to environmentally conscious investors. Overall, the trajectory points to moderate growth, tempered by regulatory and competitive headwinds.

Key Takeaways

• Amantadine hydrochloride's market has matured, with generics dominating and driving down prices, yet it offers stable revenue in niche neurological applications.
• Financial performance shows resilience amid challenges, with projected growth tied to demographic shifts and potential new indications.
• Patent expirations have commoditized the drug, underscoring the need for strategic diversification among manufacturers.
• Global expansion, particularly in Asia-Pacific, presents untapped opportunities, balanced against risks from alternatives and supply disruptions.
• Investors should monitor R&D for repurposing, as it could revitalize financial prospects in a competitive landscape.

FAQs

1. What factors are currently driving demand for amantadine hydrochloride?
   Demand is primarily fueled by the rising prevalence of Parkinson's disease in aging populations, alongside its use as an influenza A prophylactic, though efficacy against new strains remains limited.

2. How has the expiration of patents affected amantadine's pricing?
   Patent expirations have led to a significant price reduction, with generics now available at 50% or less of branded prices, as seen in U.S. and European markets.

3. What are the main competitors to amantadine in the neurological sector?
   Key competitors include levodopa and newer agents like rasagiline for Parkinson's, which offer potentially superior efficacy and have captured larger market shares.

4. Are there any upcoming regulatory changes that could impact amantadine's market?
   Potential FDA approvals for new indications, such as fatigue management in multiple sclerosis, could expand the market, while antiviral resistance guidelines may reduce its influenza role.

5. How might global economic factors influence amantadine's financial trajectory?
   Inflation and supply chain issues could increase production costs, squeezing margins, but growing healthcare spending in emerging markets may offset these effects.

Sources

1. IQVIA. "Global Pharmaceutical Market Report 2023." IQVIA Institute for Human Data Science.
2. MarketsandMarkets. "Antiviral Drugs Market Analysis 2022." MarketsandMarkets Research.
3. U.S. Food and Drug Administration. "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations." FDA.gov.
4. World Health Organization. "Parkinson's Disease Fact Sheet 2023." WHO.int.
5. Teva Pharmaceutical Industries. "Annual Financial Report 2023." Teva.com.