Rimantadine hydrochloride - Generic Drug Details

What are the generic sources for rimantadine hydrochloride and what is the scope of freedom to operate?

Rimantadine hydrochloride is the generic ingredient in two branded drugs marketed by Forest Labs, Sun Pharm Inds Inc, Chartwell Rx, Impax Labs, and Impax Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for rimantadine hydrochloride. One supplier is listed for this compound.

Summary for rimantadine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	6
Patent Applications:	2,086
What excipients (inactive ingredients) are in rimantadine hydrochloride?	rimantadine hydrochloride excipients list
DailyMed Link:	rimantadine hydrochloride at DailyMed

Recent Clinical Trials for rimantadine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Oxford	Phase 2/Phase 3
Cancer Research UK
The Leeds Teaching Hospitals NHS Trust

See all rimantadine hydrochloride clinical trials

Pharmacology for rimantadine hydrochloride

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for rimantadine hydrochloride

Antiviral Agents

Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for rimantadine hydrochloride

J05AC	Cyclic amines
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for rimantadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	RIMANTADINE HYDROCHLORIDE	rimantadine hydrochloride	TABLET;ORAL	076132-001	Aug 30, 2002		RX	No	Yes
Impax Labs Inc	RIMANTADINE HYDROCHLORIDE	rimantadine hydrochloride	TABLET;ORAL	075916-001	Nov 2, 2001		DISCN	No	No
Forest Labs	FLUMADINE	rimantadine hydrochloride	SYRUP;ORAL	019650-001	Sep 17, 1993		DISCN	No	No
Chartwell Rx	RIMANTADINE HYDROCHLORIDE	rimantadine hydrochloride	TABLET;ORAL	076375-001	Jan 14, 2003		DISCN	No	No

Rimantadine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rimantadine Hydrochloride

Introduction

Rimantadine hydrochloride, sold under the trade name Flumadine, is an orally administered antiviral drug primarily used to treat and, in some cases, prevent influenza A virus infections. Here, we will delve into the market dynamics and financial trajectory of this drug.

Historical Context and Approval

Rimantadine was discovered in 1963 and patented in 1965 by William W. Prichard at Du Pont & Co. It was approved for medical use in 1993 and by the FDA in 1994[1].

Medical Uses and Mechanism of Action

Rimantadine is effective against influenza A virus by inhibiting the M2 transmembrane channel, thereby blocking proton transport and preventing the uncoating of the virus's protective shells. This mechanism makes it a valuable treatment option when administered within one to two days of symptom onset[1].

Market Size and Growth

The influenza medication market, which includes rimantadine, was valued at US$ 907.0 million in 2022 and is projected to grow at a CAGR of 2.2% from 2023 to 2031, reaching US$ 1.1 billion by 2031. This growth is driven by the increasing need for reliable medications to manage influenza symptoms, especially among vulnerable populations such as children and the elderly[3].

Regional Market Dynamics

North America

North America held the largest share of the global influenza medication market in 2022, driven by the adoption of advanced drug therapies and increased healthcare expenditure. Rimantadine, as part of this market, benefits from these trends[3].

Europe

In Europe, awareness campaigns have led to a gradual decline in influenza cases, but the prevalence rate remains high, ensuring a significant market share for influenza medications like rimantadine[3].

Asia Pacific

The Asia Pacific region is expected to grow steadily from 2023 to 2031 due to the high incidence of influenza in developing economies such as China and India. This growth is likely to boost the demand for rimantadine and other influenza medications[3].

Competition Landscape

Rimantadine competes with other antiviral drugs such as amantadine, zanamivir, oseltamivir, and peramivir. Despite its effectiveness, rimantadine faces challenges due to resistance issues, particularly with seasonal H3N2 and 2009 pandemic flu samples showing resistance to the drug[1][3].

Resistance and Impact on Market

The emergence of resistance to rimantadine, resulting from amino acid substitutions in the M2 channel, has reduced its recommendation for flu treatment. This resistance has shifted market focus towards other antiviral drugs, affecting the financial trajectory of rimantadine[1].

Financial Performance

While specific financial data for rimantadine alone is not readily available, the overall influenza medication market trends provide insight. The market's growth is influenced by research spending, healthcare expenditure, and the need for effective treatments. However, the decline in rimantadine's usage due to resistance issues has likely impacted its financial performance negatively.

Distribution Channels

Rimantadine is distributed through various channels including hospitals, clinics, and pharmacies. The market value forecast by distribution channel indicates that these traditional healthcare settings continue to be significant for the sale of influenza medications[3].

Research and Development

Prominent players in the influenza medication market are investing heavily in R&D to develop novel drugs and address the issue of resistance. While rimantadine itself may not be a focus of new R&D efforts due to its resistance issues, the broader market dynamics drive innovation in antiviral treatments[3].

Key Takeaways

• Market Growth: The influenza medication market is growing, but rimantadine's share is impacted by resistance issues.
• Regional Dynamics: North America, Europe, and Asia Pacific are key regions, with varying growth rates and market shares.
• Competition: Rimantadine faces competition from other antiviral drugs, and its usage has declined due to resistance.
• Financial Performance: The financial trajectory of rimantadine is likely affected negatively by resistance and the shift towards other treatments.
• Distribution Channels: Traditional healthcare settings remain crucial for the distribution of influenza medications.

FAQs

What is rimantadine used for?

Rimantadine is used to treat and, in some cases, prevent influenza A virus infections.

How does rimantadine work?

Rimantadine inhibits the influenza virus by binding to the M2 transmembrane channel and blocking proton transport, preventing the uncoating of the virus's protective shells.

Why is rimantadine no longer recommended for flu treatment?

Rimantadine is no longer recommended due to the emergence of resistance, particularly in seasonal H3N2 and 2009 pandemic flu samples.

What are the common side effects of rimantadine?

Common side effects include nausea, upset stomach, nervousness, tiredness, lightheadedness, insomnia, difficulty concentrating, and confusion.

How does the market for influenza medications impact rimantadine?

The growing market for influenza medications is driven by the need for effective treatments, but rimantadine's share is reduced due to resistance issues and the availability of other antiviral drugs.

Sources

1. Wikipedia: Rimantadine
2. PubMed: Comparative single-dose pharmacokinetics of amantadine hydrochloride and rimantadine hydrochloride
3. Transparency Market Research: Influenza Medication Market Size, Growth & Forecast 2031
4. MedchemExpress: Rimantadine hydrochloride
5. FSU Physics: Differential Binding of Rimantadine Enantiomers to Influenza A M2 Channel[1][2][3][4]