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, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, 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 patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has forty-six 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:	46
US Patents:	30
Tradenames:	5
Applicants:	32
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	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No			Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No			Y
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017	AB	RX	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No
Pharm Assoc	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	SYRUP;ORAL	074509-001	Jul 17, 1995	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	2020002078	COMPOSICIONES DE AMANTADINA, PREPARACIONES DE ESTAS Y MÉTODOS DE USO. (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE.)
Japan	5325421
Spain	2549581
Japan	2023009251	アマンタジン組成物、その調製、および使用方法
Japan	2020531543	アマンタジン組成物、その調製、および使用方法

AMANTADINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amantadine Hydrochloride

Introduction to Amantadine Hydrochloride

Amantadine hydrochloride, a drug with multiple mechanisms of action, is widely used in the treatment of various neurological conditions, including Parkinson's disease, traumatic brain injury (TBI), and other disorders. Here, we delve into the market dynamics and financial trajectory of this versatile medication.

Global Market Size and Growth

The global amantadine market, which includes amantadine hydrochloride, was valued at US$ 254 million in 2023. It is anticipated to reach US$ 391.8 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period of 2024-2030[1].

Segmentation by Type and Application

The market for amantadine hydrochloride is segmented by type (high purity and low purity) and application (tablets, oral solution, and others). Hospital pharmacies, retail pharmacies, and online pharmacies are the primary distribution channels for this drug[4].

Key Players and Competitive Landscape

The market is dominated by several key players, including Chemoswed AB, Rochem International Inc, Apeloa Pharmaceutical Co, Hangzhou Longshine Bio-Tech Co, Northeast Pharmaceutical Group Co, Zhejiang Apeloa Kangyu Pharmaceutical Co, and Jiangxi Dongxu Chemical Science And Technology Co. Other notable companies in the amantadine hydrochloride market include Sine Pharma, Hengshan Pharma, Taiyi Pharma, and NE Pharma[1][4].

Geographical Distribution

The market for amantadine hydrochloride is spread across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory, influenced by local healthcare infrastructure, regulatory environments, and patient demographics[4].

Therapeutic Applications

Parkinson's Disease

Amantadine hydrochloride is a significant treatment option for Parkinson's disease, particularly in the early stages and as an adjunct to levodopa therapy. The Parkinson's disease market itself is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by advancements in diagnostic techniques and emerging therapies[3].

Traumatic Brain Injury (TBI)

The drug has shown promising results in TBI patients, offering neuroprotective and neuroactivating effects. Its NMDA receptor antagonism and ability to inhibit phosphodiesterases (PDEs) contribute to its therapeutic benefits in TBI[2].

Other Applications

Amantadine hydrochloride is also used in treating ataxia, particularly in patients with Multiple System Atrophy (MSA-C), where intravenous administration has shown significant improvement in symptoms without notable side effects[5].

Market Drivers

• Increasing Prevalence of Neurological Disorders: The rising number of cases of Parkinson's disease, TBI, and other neurological conditions drives the demand for amantadine hydrochloride.
• Advancements in Diagnostic Techniques: Improved diagnostic methods enhance the early detection and treatment of these conditions, contributing to market growth.
• Emerging Therapies: The development of new formulations, such as intravenous amantadine, and combination therapies with other drugs are expected to boost the market[2][3].

Market Challenges

• Side Effects and Safety Concerns: Amantadine hydrochloride can have side effects, particularly at higher doses, which may limit its use in some patients.
• Regulatory and Reimbursement Issues: Market access and reimbursement challenges can impede the growth of the amantadine hydrochloride market.
• Competition from Alternative Treatments: The presence of other treatment options and the increasing use of off-label treatments can affect market share and profitability[3].

Financial Projections

The global amantadine market is projected to grow significantly, with a forecasted market size of US$ 391.8 million by 2030. This growth is driven by the increasing demand for effective treatments for neurological disorders and the expanding product portfolio of key players[1].

Regional Market Performance

• Europe: The European market for amantadine is expected to grow steadily, driven by a strong healthcare infrastructure and high awareness of neurological conditions.
• North America: This region is a significant market due to the high prevalence of Parkinson's disease and TBI, along with advanced healthcare facilities.
• Asia-Pacific: The growing healthcare sector and increasing awareness of neurological disorders in this region are expected to drive market growth[1][4].

Key Takeaways

• The global amantadine hydrochloride market is growing at a CAGR of 6.4% from 2024 to 2030.
• The market is driven by increasing prevalence of neurological disorders and advancements in diagnostic techniques.
• Key players are focusing on developing new formulations and combination therapies.
• Regulatory and reimbursement issues are significant challenges to market growth.
• The drug has diverse therapeutic applications, including Parkinson's disease, TBI, and ataxia.

FAQs

What is the current market size of the amantadine hydrochloride market?

The global amantadine market was valued at US$ 254 million in 2023[1].

What is the projected growth rate of the amantadine hydrochloride market?

The market is expected to grow at a CAGR of 6.4% from 2024 to 2030[1].

What are the primary therapeutic applications of amantadine hydrochloride?

The primary applications include Parkinson's disease, traumatic brain injury (TBI), and ataxia[2][3][5].

Who are the key players in the amantadine hydrochloride market?

Key players include Chemoswed AB, Rochem International Inc, Apeloa Pharmaceutical Co, and others[1][4].

What are the main challenges facing the amantadine hydrochloride market?

Challenges include side effects, regulatory and reimbursement issues, and competition from alternative treatments[3].

Cited Sources

1. Valuates Reports: "Amantadine - Market, Report Size, Worth, Revenue, Growth, Industry..."
2. MDPI: "Amantadine for Traumatic Brain Injury—Supporting Evidence and Mode of Action"
3. GlobeNewswire: "Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034)"
4. Market Research Intellect: "Global Amantadine Hydrochloride (CAS 665-66-7) Market Size And Forecast"
5. e-JMD: "Preliminary Study of Intravenous Amantadine Treatment for Ataxia..."