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Last Updated: December 22, 2024

PROCAINAMIDE HYDROCHLORIDE - Generic Drug Details


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

Procainamide hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Parke Davis, Panray, Apothecon, Abraxis Pharm, Gland Pharma Ltd, Hikma, Hospira, Intl Medication, Nexus, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, Sandoz, Parkedale, and King Pharms, and is included in seventy-one NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for procainamide hydrochloride. Seven suppliers are listed for this compound.

Summary for PROCAINAMIDE HYDROCHLORIDE
US Patents:0
Tradenames:7
Applicants:26
NDAs:71
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 7
Raw Ingredient (Bulk) Api Vendors: 119
Clinical Trials: 16
Patent Applications: 1,968
What excipients (inactive ingredients) are in PROCAINAMIDE HYDROCHLORIDE?PROCAINAMIDE HYDROCHLORIDE excipients list
DailyMed Link:PROCAINAMIDE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for PROCAINAMIDE HYDROCHLORIDE

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

SponsorPhase
Abant Izzet Baysal UniversityN/A
Jeffrey MoakPhase 4
Ottawa Hospital Research InstitutePhase 4

See all PROCAINAMIDE HYDROCHLORIDE clinical trials

Pharmacology for PROCAINAMIDE HYDROCHLORIDE
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for PROCAINAMIDE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PROCAINAMIDE HYDROCHLORIDE

US Patents and Regulatory Information for PROCAINAMIDE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride CAPSULE;ORAL 088989-001 Apr 26, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 088534-001 Dec 3, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 089438-001 Mar 23, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 088533-001 Dec 3, 1984 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

Expired US Patents for PROCAINAMIDE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-002 Jan 31, 1996 ⤷  Subscribe ⤷  Subscribe
King Pharms PROCANBID procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 020545-001 Jan 31, 1996 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

PROCAINAMIDE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Procainamide Hydrochloride

Market Overview

Procainamide hydrochloride, a medication used to treat cardiac arrhythmias, operates within a complex and dynamic market influenced by various factors. Understanding these dynamics is crucial for stakeholders to navigate the market effectively.

Market Drivers

Increasing Prevalence of Cardiac Arrhythmias

The rising incidence of cardiac arrhythmias globally is a significant driver for the procainamide hydrochloride market. As the population ages and the prevalence of heart conditions increases, the demand for anti-arrhythmia medications like procainamide hydrochloride is expected to grow[1].

Expansion of Healthcare Facilities

The increasing number of healthcare facilities, particularly in emerging markets, is expanding the reach and accessibility of procainamide hydrochloride. This expansion enhances market penetration and increases the potential customer base[1].

Technological Advancements

Innovations in drug formulation, such as the development of extended-release tablets, and the integration of digital health technologies to monitor patient use and response, are driving market growth. These advancements improve patient compliance and efficacy, making procainamide hydrochloride more attractive to both patients and healthcare providers[1].

Market Restraints

Regulatory Challenges

Stringent regulatory requirements pose a significant barrier to market growth. The approval process for new formulations or uses of procainamide hydrochloride is rigorous, and any changes in regulatory policies can impact market dynamics[1].

Side Effects and Alternative Treatments

Procainamide hydrochloride is associated with side effects, which can deter some patients and healthcare providers. Additionally, the presence of alternative arrhythmia treatments competes directly with procainamide hydrochloride, further constraining market growth[1].

Patent Expirations and Generic Competition

The expiration of patents for procainamide hydrochloride leads to the entry of generic versions, which can significantly reduce market margins for branded products. This competition from generics is a major restraint on the market[1].

Market Opportunities

Emerging Markets

Markets with rising incidences of cardiac arrhythmias, particularly in the Asia-Pacific region, offer substantial growth opportunities. Increasing healthcare investments in these regions can drive the demand for procainamide hydrochloride[1].

Development of Affordable Generics

The development of affordable generic versions of procainamide hydrochloride can cater to budget-constrained markets, expanding the market reach and increasing overall sales volume[1].

Personalized Medicine

Research into personalized medicine approaches can create new opportunities for procainamide hydrochloride. Tailoring treatment to individual patient needs can enhance efficacy and reduce side effects, making the drug more appealing[1].

Market Challenges

Balancing Profitability and Ethical Concerns

Companies must balance profitability with ethical concerns surrounding pricing strategies. Ensuring that the drug is affordable while maintaining profitability is a significant challenge[1].

Supply Chain Management

Ensuring that the supply chain capacity meets demand is crucial. Potential raw material shortages and logistical hurdles can disrupt the supply chain, impacting market performance[1].

Differentiation in a Competitive Market

With the presence of therapeutic alternatives, companies must devise effective marketing strategies to differentiate procainamide hydrochloride. This involves highlighting the unique benefits and innovations associated with the drug[1].

Porter’s Five Forces Analysis

Threat of New Entrants

The threat of new entrants is moderate due to the regulatory hurdles and the need for significant investment in research and development. However, the potential for generic entrants is high once patents expire[1].

Bargaining Power of Suppliers

The bargaining power of suppliers can be significant, especially if there are raw material shortages or logistical issues. Companies need to maintain strong relationships with suppliers to ensure a stable supply chain[1].

Bargaining Power of Buyers

The bargaining power of buyers is relatively high, particularly for healthcare providers and insurance companies. They can negotiate prices and influence market dynamics through their purchasing decisions[1].

Threat of Substitute Products

The threat of substitute products is high due to the availability of alternative arrhythmia treatments. Companies must continuously innovate to stay competitive[1].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is intense, with several key players such as Apotex Inc., Aurobindo Pharma USA, Inc., and Pfizer Inc. vying for market share. Differentiation through innovation and strategic marketing is essential[1].

Financial Trajectory

Market Size and Growth

The procainamide hydrochloride market is expected to grow significantly from 2025 to 2030, driven by increasing demand and technological advancements. The market size is estimated in terms of sales volume and revenue, with forecasts indicating a steady growth trajectory[4].

Revenue and Profitability

The revenue from procainamide hydrochloride is influenced by the number of competitors in the market. As more generic versions enter the market, prices are expected to decline, affecting profitability. However, innovations and extended-release formulations can help maintain or increase revenue[3].

Investment and Funding

Companies are investing heavily in research and development to improve the efficacy and safety of procainamide hydrochloride. Funding for these initiatives is crucial and often comes from a combination of internal resources and external investments[1].

Key Company Profiles

Leading vendors in the procainamide hydrochloride market include Apotex Inc., Aurobindo Pharma USA, Inc., Cadila Healthcare Limited, and Pfizer Inc. These companies are known for their innovative profiles and significant developments in the market. Recent developments include new product launches, strategic investments, and advancements in manufacturing capabilities[1].

Product Development and Innovation

Extended-Release Formulations

The development of extended-release formulations is a key area of innovation. These formulations improve patient compliance by reducing the frequency of dosing, which can enhance therapeutic outcomes[1].

Integration with Digital Health Technologies

The integration of digital health technologies to monitor patient use and response is another significant area of innovation. This can provide real-time data to healthcare providers, improving treatment efficacy and safety[1].

Personalized Medicine Approaches

Research into personalized medicine approaches is ongoing. Tailoring treatment to individual patient needs can reduce side effects and improve efficacy, making procainamide hydrochloride more effective and appealing[1].

Market Penetration and Development

Current Market Landscape

The current market landscape is characterized by a mix of branded and generic products. Market penetration is influenced by the availability of healthcare facilities, regulatory approvals, and the presence of alternative treatments[1].

Expansion Opportunities

Emerging markets, particularly in the Asia-Pacific region, offer significant expansion opportunities. Increasing healthcare investments and the rising incidence of cardiac arrhythmias in these regions drive market growth[1].

Competitive Assessment and Intelligence

Market Share and Strategic Approaches

The competitive landscape is analyzed through market share, strategic approaches, product range, and certifications. Leading companies are assessed based on their market strategies, product innovations, and regulatory approvals[1].

Technology Developments

Advancements in technology, such as the development of new formulations and the integration of digital health technologies, are critical in maintaining a competitive edge. Companies that invest in these areas are better positioned to capture market share[1].

Key Takeaways

  • The procainamide hydrochloride market is driven by the increasing prevalence of cardiac arrhythmias and technological advancements.
  • Regulatory challenges, side effects, and competition from generics are significant restraints.
  • Emerging markets and the development of affordable generics offer growth opportunities.
  • Differentiation through innovation and strategic marketing is crucial in a competitive market.
  • The financial trajectory is influenced by market size, revenue, and profitability, with a focus on investment in research and development.

FAQs

What are the primary drivers of the procainamide hydrochloride market?

The primary drivers include the increasing prevalence of cardiac arrhythmias, expansion of healthcare facilities, and technological advancements such as extended-release formulations and digital health technologies[1].

What are the major restraints on the procainamide hydrochloride market?

Major restraints include stringent regulatory requirements, side effects associated with the medication, competition from alternative treatments, and the impact of patent expirations leading to generic competition[1].

How does the integration of digital health technologies impact the market?

The integration of digital health technologies helps in monitoring patient use and response, providing real-time data to healthcare providers, which can improve treatment efficacy and safety[1].

What are the key areas of innovation in the procainamide hydrochloride market?

Key areas of innovation include the development of extended-release formulations, integration with digital health technologies, and research into personalized medicine approaches[1].

Which regions offer the most significant growth opportunities for procainamide hydrochloride?

Emerging markets, particularly in the Asia-Pacific region, offer significant growth opportunities due to increasing healthcare investments and the rising incidence of cardiac arrhythmias[1].

Sources

  1. 360iResearch: Procainamide Hydrochloride Tablets Market Size 2025-2030.
  2. City of Austin: 2009 - 10 APPROVED BUDGET SUPPORTING DOCUMENTS.
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. Market Research Reports: Procainamide Hydrochloride - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
  5. MDPI: Procainamide Charge Transfer Complexes with Chloranilic Acid and 2,3-Dichloro-5,6-dicyano-1,4-benzoquinone: Experimental and Theoretical Study.

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