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Last Updated: December 28, 2024

PROTOKYLOL HYDROCHLORIDE - Generic Drug Details


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

Protokylol hydrochloride is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for PROTOKYLOL HYDROCHLORIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
Patent Applications: 75
DailyMed Link:PROTOKYLOL HYDROCHLORIDE at DailyMed

US Patents and Regulatory Information for PROTOKYLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us VENTAIRE protokylol hydrochloride TABLET;ORAL 083459-001 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

PROTOKYLOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Propranolol Hydrochloride

Introduction

Propranolol hydrochloride, a non-selective beta-blocker, has been a cornerstone in the treatment of various cardiovascular and other conditions since its introduction in the 1960s. This article delves into the market dynamics and financial trajectory of propranolol hydrochloride, examining its historical significance, current market trends, and future projections.

Historical Perspective

Propranolol, developed by Sir James Black and his team at Imperial Chemical Industries (ICI), was the first beta-blocker to be introduced into clinical practice in 1962. It revolutionized the treatment of hypertension, angina, and certain arrhythmias[4].

Therapeutic Significance

Propranolol hydrochloride is used to treat a variety of conditions, including hypertension, angina pectoris, certain types of arrhythmias, and to prevent migraine headaches. Its non-selective beta-blocking action makes it effective but also limits its use in patients with asthma or chronic obstructive pulmonary disease (COPD) due to its potential to cause bronchoconstriction[4].

Market Position

Global Pharmaceutical Market Context

The global pharmaceutical market is highly concentrated, with a significant portion of sales coming from a few industrialized countries. The United States, Japan, and major European markets account for a substantial share of global pharmaceutical sales[1].

Segment Specifics

Propranolol hydrochloride falls under the category of cardiovascular drugs, which is a large and growing segment within the pharmaceutical market. However, as a generic drug, its market dynamics differ significantly from those of newer, patented medications.

Economic Significance

Revenue and Market Share

Propranolol hydrochloride, being a generic drug, does not command the high prices associated with branded or breakthrough therapies. Its market share is significant in terms of volume but relatively small in terms of revenue compared to newer, patented drugs. The global market for generic drugs, which includes propranolol hydrochloride, was valued at $435.3 billion in 2023 and is expected to grow to $655.8 billion by 2028 at a CAGR of 8.5%[3].

Cost and Pricing

The cost of propranolol hydrochloride is generally low due to its generic status and widespread availability. This makes it accessible to a broad patient population but also limits its revenue potential for manufacturers.

Market Trends

Generic Drug Market Growth

The global generic drug market is expected to continue growing, driven by increasing demand for affordable healthcare options. This trend benefits propranolol hydrochloride, as it remains a widely prescribed generic medication[3].

Regulatory Environment

Regulatory environments in various countries influence the market dynamics of generic drugs. Expedited approval processes and favorable regulatory conditions can enhance the market penetration of generic drugs like propranolol hydrochloride[3].

Competitive Landscape

Major Players

The market for propranolol hydrochloride is highly competitive, with multiple generic manufacturers vying for market share. Companies such as Mylan Pharmaceuticals, Teva Pharmaceutical Industries, and others are key players in this segment[5].

Differentiation and Innovation

In a crowded generic market, differentiation is challenging. Manufacturers often focus on quality, reliability, and pricing to compete. Innovations in formulation, such as extended-release versions, can also provide a competitive edge.

Financial Projections

Revenue Forecast

Given the stable demand and growing generic drug market, the revenue from propranolol hydrochloride is expected to remain steady or see moderate growth. However, the exact financial projections would depend on various factors including market competition, pricing strategies, and regulatory changes.

Growth Drivers

  • Increasing Demand for Affordable Healthcare: The need for cost-effective treatments drives the demand for generic drugs like propranolol hydrochloride.
  • Expedited Approval Processes: Favorable regulatory environments can accelerate the market entry of new generic formulations.
  • Expanding Patient Population: Growing prevalence of cardiovascular diseases increases the demand for medications like propranolol hydrochloride.

Challenges and Opportunities

Challenges

  • Price Pressure: The generic market is highly competitive, leading to price pressures that can reduce profit margins.
  • Regulatory Hurdles: Changes in regulatory requirements can impact the manufacturing and distribution of generic drugs.
  • Patent Expirations: While not directly applicable to propranolol hydrochloride, patent expirations of other drugs can shift market dynamics and competition.

Opportunities

  • Emerging Markets: Expanding into emerging markets can provide new revenue streams for manufacturers of propranolol hydrochloride.
  • Innovative Formulations: Developing new formulations, such as extended-release or combination therapies, can offer competitive advantages.
  • Partnerships and Collaborations: Strategic partnerships with healthcare providers or other pharmaceutical companies can enhance market reach and penetration.

Key Takeaways

  • Propranolol hydrochloride remains a vital medication in the treatment of various cardiovascular conditions.
  • The generic drug market, including propranolol hydrochloride, is expected to grow driven by demand for affordable healthcare.
  • Regulatory environments and competitive pricing are key factors influencing the market dynamics.
  • Innovations in formulation and strategic partnerships offer opportunities for growth.

FAQs

What is the primary use of propranolol hydrochloride?

Propranolol hydrochloride is primarily used to treat hypertension, angina pectoris, certain types of arrhythmias, and to prevent migraine headaches.

How does the generic status of propranolol hydrochloride affect its market dynamics?

The generic status of propranolol hydrochloride results in lower prices and higher volume sales but also leads to intense competition and lower profit margins.

What are the key growth drivers for the market of propranolol hydrochloride?

Key growth drivers include increasing demand for affordable healthcare, expedited approval processes, and an expanding patient population due to growing prevalence of cardiovascular diseases.

How does the regulatory environment impact the market for propranolol hydrochloride?

The regulatory environment can significantly impact the market by influencing approval processes, manufacturing standards, and distribution channels.

What opportunities exist for manufacturers of propranolol hydrochloride to differentiate themselves?

Manufacturers can differentiate themselves through innovative formulations, strategic partnerships, and expansion into emerging markets.

Sources

  1. UNODC: "AMPHETAMINE-TYPE STIMULANTS A GLOBAL REVIEW"[1]
  2. DrugBank: "Isoetharine: Uses, Interactions, Mechanism of Action"[2]
  3. BCC Research: "Global Breakthrough Therapies Market Size and Growth Forecast"[3]
  4. Revespcardiol: "Beta-blockers: Historical Perspective and Mechanisms of Action"[4]
  5. California Department of Justice: "Fortieth Annual Report"[5]

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