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Last Updated: December 22, 2024

BIPERIDEN HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for biperiden hydrochloride and what is the scope of patent protection?

Biperiden hydrochloride is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for biperiden hydrochloride.

Summary for BIPERIDEN HYDROCHLORIDE
Recent Clinical Trials for BIPERIDEN HYDROCHLORIDE

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

SponsorPhase
Hospital Sirio-LibanesPhase 3
PROADI-SUSPhase 3
Ministry of Health, BrazilPhase 3

See all BIPERIDEN HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BIPERIDEN HYDROCHLORIDE

US Patents and Regulatory Information for BIPERIDEN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie AKINETON biperiden hydrochloride TABLET;ORAL 012003-001 Approved Prior to Jan 1, 1982 DISCN No 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

BIPERIDEN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Biperiden Hydrochloride

Introduction

Biperiden hydrochloride, an anticholinergic agent, is widely used for its antispasmodic and antiparkinsonian properties. The market for biperiden hydrochloride is influenced by several key factors, including the rising prevalence of Parkinson's disease, advancements in drug delivery systems, and the expanding geriatric population.

Market Drivers

Growing Prevalence of Parkinson's Disease

The increasing number of Parkinson's disease cases globally is a significant driver for the biperiden hydrochloride market. As older age groups are more prone to Parkinson's, the expanding elderly demographic fosters a growing need for this medication[3].

Rising Usage in Drug-Induced Movement Disorders

Biperiden hydrochloride is also used to counteract the side effects of antipsychotic medications, such as involuntary muscle movements. This dual application further boosts its demand[3].

Advancements in Drug Delivery Systems

Recent innovations in drug delivery and formulation present potential opportunities for market players. Research into alternative drug delivery systems, such as transdermal patches or sustained-release forms, can provide a competitive edge[1].

Market Restraints

Limited Awareness and High Manufacturing Costs

Despite its clinical significance, the biperiden hydrochloride market faces challenges such as limited awareness and the high cost of manufacturing. These factors can restrict market growth and penetration, especially in regions with limited healthcare resources[1].

Potential Health Effects

Biperiden hydrochloride is associated with anticholinergic side effects, including dry mouth, blurred vision, and constipation. These side effects can limit its usability for some patients and necessitate careful management under healthcare professional guidance[3].

Market Opportunities

Ongoing Research and Development

Continuous research aimed at improving the efficacy of biperiden hydrochloride and reducing its side effects contributes to market growth. Innovations in drug delivery and the potential for personalized medicine approaches, such as genetic markers for Parkinson's disease, offer significant opportunities[1].

Emerging Investments in Pharmaceutical Production

Pharmaceutical companies are increasingly investing in biperiden production, driven by the growing demand for effective treatments for Parkinson's disease and other related disorders. This investment is expected to enhance production capacities and improve product quality[1].

Market Segmentation

Administration

The biperiden hydrochloride market is segmented by administration into oral and injectable forms. Oral administration is increasingly preferred due to its ease of use and high patient compliance[3].

Application

Biperiden hydrochloride is used in various applications, including the treatment of Parkinson's disease, drug-induced movement disorders, and Tourette syndrome. The proliferation of biperiden in drug-induced movement disorders as a potent anticholinergic agent is particularly noteworthy[1].

Geographic Regions

The market is segmented geographically into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas, particularly the United States, have a robust healthcare infrastructure and high awareness of neurological disorders, driving significant demand. The Asia-Pacific region, with countries like China and India, offers substantial growth potential due to their large population bases and evolving healthcare sectors[3].

Financial Trajectory

Current Market Size

The biperiden hydrochloride market size was estimated at USD 364.27 million in 2023 and is expected to reach USD 384.70 million in 2024. This growth is projected to continue, with the market expected to reach USD 536.76 million by 2030 at a CAGR of 5.69%[3].

Regional Market Performance

  • Americas: The United States is the largest market in this region, driven by an aging population and the prevalence of Parkinson's disease. Latin America also shows promising growth potential due to improving healthcare facilities and rising healthcare expenditures[3].
  • Asia-Pacific: Countries like China and India are pivotal due to their immense population bases and rapidly evolving healthcare sectors. Increased investments in healthcare infrastructure and growing middle-class populations are key factors propelling the market in this region[3].
  • Europe, Middle East & Africa: Europe stands out as a central market, supported by advanced healthcare systems, high spending on healthcare, and an increasing incidence of Parkinson's disease[3].

Competitive Landscape

The biperiden hydrochloride market is moderately competitive, with several key players including Abbott Laboratories, AbbVie Inc., ACTYLIS, Adooq Bioscience LLC, and others. These companies are recommended to invest in R&D for novel drug formulations and strategic collaborations to expand their market presence[1][3].

Porter’s Five Forces Analysis

Threat of New Entrants

The threat of new entrants is moderate due to the need for significant investments in R&D and the stringent regulatory approval processes involved in the pharmaceutical industry[1].

Threat of Substitutes

The threat of substitutes is relatively high due to the presence of other anticholinergic agents and alternative treatments for Parkinson's disease and related disorders[1].

Bargaining Power of Customers

The bargaining power of customers is moderate, influenced by factors such as patient compliance, ease of use, and the availability of different administration forms[1].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low due to the availability of raw materials and the competitive nature of the supplier market[1].

Industry Rivalry

Industry rivalry is high, driven by the need for therapeutic efficacy, safety profile, and cost-effectiveness. Innovation and strategic collaborations are paramount for leveraging growth in this evolving market landscape[1].

PESTLE Analysis

Political

Regulatory approvals and insurance coverage policies significantly influence the market dynamics. Favorable regulatory environments in regions like Europe support market growth[3].

Economic

High spending on healthcare in regions like Europe and the increasing healthcare expenditures in emerging markets drive market growth[3].

Social

The growing awareness of neurological disorders and the expanding elderly demographic are key social factors driving the demand for biperiden hydrochloride[1].

Technological

Advancements in drug delivery systems and the adoption of IoT and AI in precision medicine offer groundbreaking opportunities for the application and delivery of biperiden hydrochloride[1].

Legal

Stringent regulatory approval processes and the need for careful navigation of intellectual property rights are significant legal challenges in the market[1].

Environmental

The environmental impact of pharmaceutical production is a consideration, but it is not a primary factor influencing the biperiden hydrochloride market dynamics[1].

Preparation Methods and Innovations

New Preparation Processes

Recent inventions have introduced new preparation processes for biperiden hydrochloride that meet European Pharmacopoeia standards. These methods involve the use of easily accessible raw materials, mild reaction conditions, and high yields, making them suitable for industrial production[2][5].

Key Takeaways

  • The biperiden hydrochloride market is driven by the rising prevalence of Parkinson's disease and advancements in drug delivery systems.
  • The market faces challenges such as limited awareness, high manufacturing costs, and potential side effects.
  • Ongoing research and development, along with emerging investments in pharmaceutical production, offer significant growth opportunities.
  • The market is segmented by administration, application, and geographic regions, with the Americas and Asia-Pacific regions showing substantial growth potential.
  • The competitive landscape is moderately competitive, with key players focusing on R&D and strategic collaborations.

FAQs

What are the primary drivers of the biperiden hydrochloride market?

The primary drivers include the growing prevalence of Parkinson's disease, advancements in drug delivery systems, and the expanding geriatric population.

What are the main challenges facing the biperiden hydrochloride market?

The main challenges include limited awareness, high manufacturing costs, and potential anticholinergic side effects.

How is the biperiden hydrochloride market segmented?

The market is segmented by administration (oral and injectable), application (Parkinson's disease, drug-induced movement disorders, and Tourette syndrome), and geographic regions (Americas, Asia-Pacific, and Europe, Middle East & Africa).

What is the projected financial trajectory of the biperiden hydrochloride market?

The market is expected to grow from USD 364.27 million in 2023 to USD 536.76 million by 2030 at a CAGR of 5.69%.

Which regions offer the most significant growth potential for the biperiden hydrochloride market?

The Asia-Pacific region, particularly countries like China and India, and the Americas, especially the United States, offer substantial growth potential due to their large population bases and evolving healthcare sectors.

Sources

  1. Research and Markets: Biperiden Market Size, Competitors & Forecast to 2030.
  2. Google Patents: The preparation method that biperiden hydrochloride is new.
  3. GII Research: Biperiden Market by Administration, Application.
  4. News Channel Nebraska: Biperiden Hydrochloride Tablet Market Size Insights Report 2024-2032.
  5. Google Patents: Biperiden hydrochloride preparation method.

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