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Last Updated: December 27, 2024

BROMODIPHENHYDRAMINE HYDROCHLORIDE - Generic Drug Details


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

Bromodiphenhydramine hydrochloride is the generic ingredient in four branded drugs marketed by Parke Davis, Forest Labs, Alpharma Us Pharms, and Wockhardt, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for bromodiphenhydramine hydrochloride.

Summary for BROMODIPHENHYDRAMINE HYDROCHLORIDE

US Patents and Regulatory Information for BROMODIPHENHYDRAMINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs AMBENYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 009319-006 Jan 10, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alpharma Us Pharms BROMANYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088343-001 Aug 15, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis AMBODRYL bromodiphenhydramine hydrochloride CAPSULE;ORAL 007984-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088626-001 Oct 12, 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

BROMODIPHENHYDRAMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bromodiphenhydramine Hydrochloride

Introduction to Bromodiphenhydramine Hydrochloride

Bromodiphenhydramine hydrochloride is an ethanolamine antihistamine, known for its significant antimuscarinic activity and its use in treating various allergic and non-allergic conditions. This drug competes with free histamine for binding at H1-receptor sites, thereby reducing the negative symptoms associated with histamine release[4][5].

Market Demand and Growth Drivers

Increasing Prevalence of Allergies

The global market for antihistamines, including bromodiphenhydramine hydrochloride, is driven by the rising prevalence of allergy disorders such as hay fever and chronic urticaria. As the incidence of these conditions increases, so does the demand for effective antihistamine treatments[3].

Seasonal Variations

Antihistamine sales, including those of bromodiphenhydramine hydrochloride, exhibit seasonal peaks, particularly during the spring and summer months when pollen levels are higher. This seasonal demand can significantly impact the financial trajectory of the drug[1].

Non-Drowsy Formulations

Bromodiphenhydramine hydrochloride, while primarily sedating, benefits from the broader trend towards non-drowsy antihistamines. However, its sedative properties can also be a selling point for specific indications like motion sickness and mild cases of Parkinson's disease[4][5].

Expanding Healthcare Infrastructure

The growth in healthcare infrastructure and the increasing availability of over-the-counter (OTC) drugs contribute to the market expansion. As more people gain access to healthcare services and OTC medications, the demand for bromodiphenhydramine hydrochloride is likely to increase[3].

Market Size and Forecast

While specific financial data for bromodiphenhydramine hydrochloride is not readily available, the broader antihistamine market provides a context. The global fexofenadine hydrochloride market, for example, was valued at USD 3.5 billion in 2023 and is expected to reach USD 4.5 billion by 2031, growing at a CAGR of 3.5% from 2024 to 2031. This growth trend can be indicative of the overall antihistamine market, including bromodiphenhydramine hydrochloride[3].

Competitive Landscape

Generational Shift in Antihistamines

The antihistamine market is witnessing a shift towards newer generations of drugs. Second and third-generation antihistamines, which offer better pharmacotherapeutic advantages over first-generation drugs like bromodiphenhydramine, are gaining popularity. However, bromodiphenhydramine's unique properties, such as its antimicrobial activity and use in treating motion sickness, maintain its relevance in the market[1].

Pricing and Affordability

The affordability of bromodiphenhydramine hydrochloride is a crucial factor in its market dynamics. The drug's pricing, often within the range of $1.38 to $6.88 for similar antihistamines, makes it accessible to a wide range of consumers, contributing to its sales and revenue[1].

Financial Performance

Sales Volumes and Seasonal Peaks

Sales data for antihistamines like bromodiphenhydramine hydrochloride show significant seasonal variations. Peak sales occur during the spring and summer months, reflecting the increased demand during pollen seasons. For instance, in the regional pharmaceutical market analyzed, the highest sales volumes were recorded from April to September, with sales reaching up to 11.1% of the total annual sales in August[1].

Revenue Impact

The sales of bromodiphenhydramine hydrochloride contribute to the overall revenue of pharmacy organizations. The affordable pricing and high demand during peak seasons ensure that the drug remains a profitable item in the pharmaceutical retail market. The revenue generated from such sales helps in maintaining the economic and physical accessibility of these drugs to the general population[1].

Consumer Preferences and Behavior

Preference for Non-Drowsy Options

While bromodiphenhydramine hydrochloride is known for its sedative effects, consumer preference is increasingly shifting towards non-drowsy antihistamines. However, for specific indications where sedation is beneficial, bromodiphenhydramine remains a preferred choice[4][5].

Impact of Healthcare Infrastructure

The expanding healthcare infrastructure and increased access to OTC medications influence consumer behavior. More people are seeking reliable and practical allergy treatment options, which includes bromodiphenhydramine hydrochloride[3].

Regulatory Environment

State Regulation and Pricing

Pharmaceutical organizations must comply with state regulations regarding the maximum selling prices of antihistamines, including bromodiphenhydramine hydrochloride. This ensures that the drugs remain affordable and accessible to the general population[1].

Institutional Requirements

The availability of bromodiphenhydramine hydrochloride in the distribution network is governed by institutional requirements that mandate its inclusion in the minimum range of drugs. This ensures that the drug is consistently available in pharmacies[1].

Future Outlook

Continuous Improvements in Formulations

Advancements in pharmaceutical science are expected to enhance the effectiveness and availability of bromodiphenhydramine hydrochloride. New formulations and delivery methods could further boost its market presence[3].

Growing Awareness and Disposable Incomes

Increasing awareness of allergy management and growing disposable incomes are likely to drive the demand for bromodiphenhydramine hydrochloride. As more people seek reliable allergy treatment options, the market for this drug is expected to grow[3].

Key Takeaways

  • Seasonal Demand: Sales of bromodiphenhydramine hydrochloride peak during spring and summer due to increased pollen levels.
  • Market Growth: The antihistamine market, including bromodiphenhydramine hydrochloride, is driven by the rising prevalence of allergies and expanding healthcare infrastructure.
  • Competitive Landscape: Despite the shift towards newer generations of antihistamines, bromodiphenhydramine hydrochloride maintains its market presence due to its unique properties.
  • Financial Performance: The drug contributes significantly to pharmacy revenues, especially during peak seasons.
  • Regulatory Environment: State regulations and institutional requirements ensure the drug's affordability and availability.

FAQs

What are the primary uses of bromodiphenhydramine hydrochloride?

Bromodiphenhydramine hydrochloride is used to treat cutaneous allergies, motion sickness, and mild cases of Parkinson's disease. It also has antimicrobial properties and is used to treat irritant cough and other related symptoms[4][5].

How does bromodiphenhydramine hydrochloride compare to other antihistamines?

Bromodiphenhydramine hydrochloride is a first-generation antihistamine with significant antimuscarinic activity, which distinguishes it from newer generations of antihistamines that are non-drowsy. However, its unique properties maintain its relevance in the market[1][4].

What are the seasonal trends in the sales of bromodiphenhydramine hydrochloride?

Sales of bromodiphenhydramine hydrochloride peak during the spring and summer months due to the increased pollen levels and associated allergy symptoms[1].

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

State regulations ensure that the maximum selling prices of bromodiphenhydramine hydrochloride are controlled, making the drug affordable and accessible to the general population. Institutional requirements also mandate its inclusion in the minimum range of drugs available in pharmacies[1].

What are the future prospects for bromodiphenhydramine hydrochloride in the market?

The market for bromodiphenhydramine hydrochloride is expected to grow due to advancements in pharmaceutical science, increasing awareness of allergy management, and growing disposable incomes. New formulations and delivery methods could further enhance its market presence[3].

Sources

  1. Antihistamines: research and analysis of the regional retail market. Consilium.
  2. Diphenhydramine: Uses, Interactions, Mechanism of Action. DrugBank.
  3. Fexofenadine Hydrochloride Market Size, Share and Trends [2024 .... Market Research Intellect.
  4. Bromodiphenhydramine: Uses, Interactions, Mechanism of Action. DrugBank.
  5. Bromodiphenhydramine | Drug Information, Uses, Side Effects .... Pharma Compass.

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