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Last Updated: December 22, 2024

HISTAFED Drug Patent Profile


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Summary for HISTAFED
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 33
Patent Applications: 5,256
DailyMed Link:HISTAFED at DailyMed
Drug patent expirations by year for HISTAFED

US Patents and Regulatory Information for HISTAFED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cenci HISTAFED pseudoephedrine hydrochloride; triprolidine hydrochloride SYRUP;ORAL 088283-001 Apr 20, 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

HISTAFED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Histafed

Introduction

Histafed, a combination antihistamine and decongestant, is widely used to treat symptoms of allergies and the common cold. To understand its market dynamics and financial trajectory, it is crucial to delve into various aspects including its usage, regulatory environment, competitive landscape, and financial implications.

What is Histafed?

Histafed is a medication that combines pseudoephedrine and triprolidine to treat runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies or the common cold[4].

Market Demand and Usage

The demand for Histafed and similar medications is driven by the prevalence of allergies and common colds. Given that these conditions are widespread, the market for such medications remains robust. However, the usage of Histafed can be influenced by seasonal variations, with higher demand during peak allergy and cold seasons.

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of Histafed. Pseudoephedrine, a key ingredient in Histafed, is subject to strict regulations due to its potential for misuse in the production of methamphetamine. The DEA closely monitors the sales and distribution of pseudoephedrine-containing products, which can impact the availability and pricing of Histafed[1][2].

Impact of Sales Restrictions

Studies have shown that sales restrictions on pseudoephedrine can significantly affect the market. For instance, the implementation of sales restrictions led to a median year-over-year decrease in retail outlet sales of pseudoephedrine products, ranging from -11.9% to -45.2% in different periods and channels[1]. This regulatory oversight can limit the financial growth of Histafed by restricting its sales volume.

Competitive Landscape

The market for antihistamine and decongestant medications is highly competitive. Histafed competes with other brand names and generic versions of similar medications. The competition is further intensified by the presence of other treatments for allergies and colds, such as prednisone, fluticasone nasal, cetirizine, and montelukast[4].

Entry Barriers and Competitive Entry

The pharmaceutical industry is characterized by high entry barriers, but the trend suggests that these barriers have decreased over time. Follow-on drugs, which include generic and similar versions of existing medications, enter the market more quickly than in the past. This increased competitiveness can pressure the pricing and market share of Histafed[3].

Financial Trajectory

Sales Volume and Revenue

The financial performance of Histafed is closely tied to its sales volume, which can be affected by regulatory restrictions and competitive pressures. Despite these challenges, Histafed remains a significant player in the market due to its established brand and efficacy.

Cost Structure

The cost structure for Histafed includes manufacturing costs, regulatory compliance expenses, and marketing expenditures. The strict regulatory environment increases the cost of compliance, which can be a significant financial burden. Additionally, the need to maintain a strong brand presence in a competitive market adds to the overall cost[2].

Pricing Strategies

Pricing strategies for Histafed must balance the need to remain competitive with the necessity of covering costs and generating profit. Given the regulatory restrictions and competitive landscape, pricing may be adjusted to reflect changes in market conditions and consumer demand.

Side Effects and Safety Concerns

The financial trajectory of Histafed can also be influenced by safety concerns and side effects. Serious side effects, such as severe dizziness, nervousness, and high blood pressure, can lead to decreased consumer confidence and potential legal liabilities. Ensuring safety and managing side effects are critical to maintaining market share and avoiding financial setbacks[4].

Distribution and Sales Channels

Histafed is distributed through various channels, including retail pharmacies, convenience stores, and online platforms. The effectiveness of these distribution channels can impact the financial performance of the product. Regulatory requirements, such as those related to pseudoephedrine sales, must be strictly adhered to across all distribution channels[1].

Consumer Preferences and Brand Loyalty

Consumer preferences and brand loyalty play a crucial role in the financial success of Histafed. Building and maintaining a strong brand reputation through effective marketing and customer satisfaction can help mitigate the effects of regulatory and competitive pressures.

Future Outlook

The future outlook for Histafed is influenced by several factors, including changes in regulatory policies, advancements in medical treatments, and shifts in consumer preferences. As the pharmaceutical industry continues to evolve, Histafed must adapt to remain a viable option in the market.

Regulatory Changes

Any changes in the regulatory environment, such as stricter controls on pseudoephedrine or new guidelines for over-the-counter medications, could significantly impact the market dynamics and financial trajectory of Histafed.

Technological Advancements

Advancements in medical technology and the development of new treatments could pose challenges to Histafed's market share. However, these advancements could also present opportunities for innovation and differentiation.

Key Takeaways

  • Regulatory Impact: Strict regulations on pseudoephedrine significantly affect the sales and distribution of Histafed.
  • Competitive Landscape: The market is highly competitive, with multiple brand names and generic versions available.
  • Financial Performance: Sales volume, regulatory compliance costs, and pricing strategies are key factors influencing the financial trajectory.
  • Safety Concerns: Managing side effects and ensuring safety are crucial for maintaining consumer confidence and avoiding financial setbacks.
  • Distribution Channels: Effective distribution through various channels is essential for market success.

FAQs

What are the main ingredients in Histafed?

Histafed contains pseudoephedrine and triprolidine, which are used to treat symptoms of allergies and the common cold[4].

How does the regulatory environment affect Histafed?

The regulatory environment, particularly the strict controls on pseudoephedrine, can limit the sales volume and distribution of Histafed, impacting its financial performance[1][2].

What are the potential side effects of Histafed?

Histafed can cause serious side effects such as severe dizziness, nervousness, and high blood pressure. Common side effects include dizziness, drowsiness, and dry mouth[4].

How competitive is the market for Histafed?

The market for antihistamine and decongestant medications is highly competitive, with multiple brand names and generic versions available. This competition can pressure the pricing and market share of Histafed[3][4].

What factors influence the financial trajectory of Histafed?

The financial trajectory of Histafed is influenced by sales volume, regulatory compliance costs, pricing strategies, safety concerns, and consumer preferences[1][2][4].

Sources

  1. DEA IMS study - Methodology Used in Developing Preliminary Estimates of Ephedrine and Pseudoephedrine Usage[1].
  2. DEA Compliance Manual - Rules and regulations for controlled substances[2].
  3. The economics of follow-on drug research and development - Trends in competitive entry in the pharmaceutical marketplace[3].
  4. Histafed Uses, Side Effects & Warnings - Detailed information on Histafed from Drugs.com[4].

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