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Last Updated: December 22, 2024

FLUMADINE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Flumadine

A generic version of FLUMADINE was approved as rimantadine hydrochloride by IMPAX LABS on August 30th, 2002.

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US Patents and Regulatory Information for FLUMADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs FLUMADINE rimantadine hydrochloride SYRUP;ORAL 019650-001 Sep 17, 1993 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc FLUMADINE rimantadine hydrochloride TABLET;ORAL 019649-001 Sep 17, 1993 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FLUMADINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flumadine (Rimantadine)

Market Overview of Influenza Medications

The influenza medication market is driven by several key factors, including the heightened number of influenza cases, the need for reliable medications, and increased healthcare expenditures. This market 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[1].

Flumadine (Rimantadine): An Overview

Flumadine, also known as rimantadine hydrochloride, is a synthetic antiviral drug used to treat and prevent influenza A virus infections. It is available in the form of 100 mg film-coated tablets and as a syrup for oral administration[2].

Mechanism of Action

Rimantadine works by inhibiting the M2 ion channel of the influenza A virus, thereby preventing the virus from replicating. However, due to widespread resistance, it is no longer recommended for use against current strains of influenza A[4].

Historical Market Performance

Sales and Revenue

Historically, rimantadine was one of the drugs used to manage influenza A infections. However, its market share has declined significantly due to the emergence of resistant viral strains and the introduction of newer antiviral drugs like oseltamivir, zanamivir, and peramivir.

Market Share

In the past, rimantadine held a notable share in the influenza medication market, but its usage has been largely phased out due to resistance issues. The oseltamivir product segment now holds the largest share in the market[1].

Current Market Dynamics

Decline in Usage

The decline in the use of rimantadine is attributed to the high prevalence of resistant influenza A virus strains. This has led to a shift towards other antiviral drugs that are more effective against current viral strains.

Regulatory Status

Rimantadine is no longer recommended by the FDA for the treatment or prophylaxis of influenza A due to widespread resistance. This has significantly impacted its market dynamics and financial trajectory[4].

Financial Trajectory

Revenue Impact

The revenue generated from rimantadine has seen a substantial decline over the years. As the drug is no longer recommended, its sales have plummeted, and it no longer contributes significantly to the overall influenza medication market revenue.

Cost and Pricing

The cost of developing and manufacturing antiviral drugs, including rimantadine, is high. For instance, the R&D cost for a successful vaccine can range from US$ 200 million to US$ 500 million, with additional costs for manufacturing infrastructure[1].

Competition

The market is now dominated by other antiviral drugs such as oseltamivir, zanamivir, and peramivir, which have better efficacy and lower resistance rates. This competition has further reduced the financial viability of rimantadine.

Distribution and Sales Channels

Distribution Channels

Rimantadine, like other influenza medications, was distributed through various channels including hospitals, clinics, and pharmacies. However, its distribution has significantly decreased due to its non-recommended status[1].

Adverse Events and Safety Profile

Adverse Events

Rimantadine has been associated with several adverse events, particularly involving the gastrointestinal and nervous systems. Common adverse events include insomnia, dizziness, headache, and nausea. These side effects, although manageable, have contributed to the preference for other antiviral drugs with better safety profiles[2].

Future Outlook

Replacement by Newer Drugs

The future outlook for rimantadine is bleak due to its non-recommended status and the availability of more effective and safer alternatives. The market is expected to continue growing, driven by the demand for newer antiviral drugs.

Research and Development

Prominent players in the influenza medication market are investing heavily in the R&D of novel drugs and vaccines. This focus on innovation is likely to further marginalize rimantadine and other older antiviral drugs[1].

Key Takeaways

  • Decline in Usage: Rimantadine's usage has declined significantly due to widespread resistance and the introduction of newer antiviral drugs.
  • Regulatory Status: It is no longer recommended by the FDA for influenza A treatment or prophylaxis.
  • Financial Impact: The revenue generated from rimantadine has seen a substantial decline.
  • Competition: The market is dominated by other antiviral drugs with better efficacy and lower resistance rates.
  • Distribution: Its distribution has decreased significantly due to its non-recommended status.

FAQs

What is the current status of rimantadine in the influenza medication market?

Rimantadine is no longer recommended by the FDA for the treatment or prophylaxis of influenza A due to widespread resistance.

Why has the usage of rimantadine declined?

The usage of rimantadine has declined due to the high prevalence of resistant influenza A virus strains and the introduction of newer, more effective antiviral drugs.

What are the common adverse events associated with rimantadine?

Common adverse events include insomnia, dizziness, headache, and nausea, particularly involving the gastrointestinal and nervous systems.

How has the financial trajectory of rimantadine been affected?

The revenue generated from rimantadine has seen a substantial decline due to its non-recommended status and the preference for other antiviral drugs.

What are the alternatives to rimantadine in the market?

Alternatives include oseltamivir, zanamivir, peramivir, and baloxavir marboxil, which are currently recommended by the FDA for influenza treatment and prophylaxis.

Sources

  1. Transparency Market Research: Influenza Medication Market Size, Growth & Forecast 2031.
  2. FDA: FlumadineĀ® Tablets (rimantadine hydrochloride) - Label.
  3. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
  4. ASM Journals: The current state of research on influenza antiviral drug.

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