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Last Updated: December 22, 2024

ISOPTIN Drug Patent Profile


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When do Isoptin patents expire, and when can generic versions of Isoptin launch?

Isoptin is a drug marketed by Mt Adams and is included in two NDAs.

The generic ingredient in ISOPTIN is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Isoptin

A generic version of ISOPTIN was approved as verapamil hydrochloride by EXELA PHARMA on March 30th, 1984.

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Summary for ISOPTIN
Drug patent expirations by year for ISOPTIN
Recent Clinical Trials for ISOPTIN

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

SponsorPhase
Assiut UniversityN/A
Assiut UniversityEarly Phase 1
ZonMw: The Netherlands Organisation for Health Research and DevelopmentN/A

See all ISOPTIN clinical trials

US Patents and Regulatory Information for ISOPTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mt Adams ISOPTIN verapamil hydrochloride INJECTABLE;INJECTION 018485-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mt Adams ISOPTIN verapamil hydrochloride TABLET;ORAL 018593-002 Mar 8, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mt Adams ISOPTIN verapamil hydrochloride TABLET;ORAL 018593-003 Nov 23, 1987 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mt Adams ISOPTIN verapamil hydrochloride TABLET;ORAL 018593-001 Mar 8, 1982 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

ISOPTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ISOPTIN (Verapamil)

Introduction

ISOPTIN, commonly known by its generic name verapamil, is a calcium channel blocker used primarily to treat hypertension, angina, and certain heart rhythm disorders. Understanding the market dynamics and financial trajectory of verapamil is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Drivers

The demand for verapamil is driven by several key factors:

Growing Prevalence of Hypertension and Cardiovascular Diseases

The increasing incidence of hypertension and related cardiovascular conditions, largely due to lifestyle factors such as poor dietary habits and sedentary lifestyles, has significantly elevated the demand for medications like verapamil[1].

Focus on Preventive Medicine

There is a growing trend toward preventive medicine and early intervention in healthcare. This shift has led healthcare providers to emphasize controlling blood pressure and heart health to prevent more severe cardiovascular events, further boosting the demand for verapamil[1].

Aging Population

The expanding aging population is more susceptible to cardiovascular issues, making verapamil a crucial component of their treatment regimens. This demographic shift contributes to the steady growth of the verapamil market[1].

Availability of Generic Versions

The emergence of generic versions of verapamil has increased affordability and accessibility for patients, driving demand and market expansion. Generic versions have become a significant factor in the pharmaceutical industry, especially since the Drug Price Competition and Patent Term Restoration Act of 1984[3][4].

Market Landscape

Global Market Overview

The global verapamil market is segmented by region and product type. The report by IMARC Group provides a detailed segment-wise and region-wise breakup of the global verapamil industry, including price analysis of feedstocks and industry profit margins[1].

Competitive Dynamics

The pharmaceutical industry, including the market for verapamil, is characterized by intense competition. Brand-name pharmaceutical companies face increasing competition from generic drug companies. The entry of multiple generic producers leads to a decline in prices, as generic drug prices fall with the number of competitors and begin to approach long-run marginal costs when there are 8 or more competitors[4].

Manufacturing and Production

Plant Setup and Machinery

Setting up a verapamil manufacturing plant involves several critical steps, including the selection of appropriate machinery and technology. The IMARC Group report provides detailed insights into the process flow, unit operations, and raw material requirements necessary for verapamil production. It also covers the necessary quality assurance criteria and technical tests[1].

Raw Materials and Utility Requirements

The production of verapamil requires specific raw materials and utilities. The report outlines the mass balance and raw material requirements, ensuring that manufacturers can plan and execute the production process efficiently[1].

Financial Analysis

Project Economics

The financial trajectory of a verapamil manufacturing plant is influenced by several economic factors. The IMARC Group report provides a comprehensive analysis of project economics, including capital investments, project funding, operating expenses, income and expenditure projections, fixed and variable costs, and expected ROI and NPV. It also includes a detailed financial analysis, profitability analysis, payback period, and sensitivity analysis[1].

Cost and Revenue Projections

The cost structure for verapamil production includes capital expenditure (CapEx), operating expenditure (OpEx), and other financial metrics. Revenue projections are based on market demand, pricing strategies, and competitive dynamics. The report helps in understanding the financial viability of the project through detailed income and expenditure projections[1].

Regulatory and Legal Considerations

Regulatory Procedures and Approvals

Setting up a verapamil manufacturing plant requires compliance with various regulatory procedures and approvals. The report covers the necessary certifications, financial assistance, and regulatory requirements to ensure that the plant operates within legal and ethical boundaries[1].

Antitrust and Competitive Issues

The pharmaceutical industry is subject to antitrust regulations, particularly in the context of vertical consolidation and differential pricing. The FTC report highlights potential antitrust concerns, such as anticompetitive exchanges of information and vertical contracting practices, which could impact the market dynamics of verapamil[3].

Market Trends and Future Outlook

Generic Market Dynamics

The generic drug market, including verapamil, is characterized by rapid entry and competition. More firms enter markets with greater expected rents, and prices decline as the number of competitors increases. This trend is expected to continue, influencing the market dynamics and pricing strategies for verapamil[4].

Emerging Therapeutic Uses

Research into the potential preventive and therapeutic roles of verapamil in other conditions, such as Alzheimer's disease, may open new market opportunities. However, these are still in the experimental and clinical stages and require further validation[2].

Key Takeaways

  • The verapamil market is driven by the growing prevalence of hypertension and cardiovascular diseases, a focus on preventive medicine, an aging population, and the availability of generic versions.
  • Setting up a verapamil manufacturing plant requires detailed planning of plant setup, machinery, raw materials, and regulatory compliance.
  • Financial analysis includes project economics, cost and revenue projections, and regulatory considerations.
  • The market is highly competitive, with generic versions playing a significant role in pricing and market dynamics.
  • Emerging therapeutic uses could expand the market potential of verapamil.

FAQs

Q: What are the primary drivers of the verapamil market?

The primary drivers include the growing prevalence of hypertension and cardiovascular diseases, a focus on preventive medicine, an aging population, and the availability of generic versions.

Q: How does the entry of generic producers affect the verapamil market?

The entry of generic producers leads to a decline in prices as the number of competitors increases. Prices begin to approach long-run marginal costs when there are 8 or more competitors.

Q: What are the key considerations for setting up a verapamil manufacturing plant?

Key considerations include plant setup, machinery and technology requirements, raw material and utility requirements, regulatory compliance, and detailed financial analysis.

Q: How does the regulatory environment impact the verapamil market?

The regulatory environment, including antitrust regulations and approvals, significantly impacts the market dynamics. Compliance with regulatory procedures is crucial for the operation of a verapamil manufacturing plant.

Q: Are there any emerging therapeutic uses for verapamil?

Yes, there is ongoing research into the potential preventive and therapeutic roles of verapamil in conditions such as Alzheimer's disease, although these are still in the experimental stages.

Sources

  1. IMARC Group, "Verapamil (Isoptin) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue."
  2. Frontiers in Pharmacology, "Verapamil and Alzheimer's Disease: Past, Present, and Future."
  3. Federal Trade Commission, "A Discussion of Competitive and Antitrust Issues in an Environment of Change."
  4. Federal Trade Commission, "Generic Drug Industry Dynamics."

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