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Last Updated: December 22, 2024

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for brompheniramine maleate; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Brompheniramine maleate; pseudoephedrine hydrochloride is the generic ingredient in one branded drug marketed by Alza and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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US Patents and Regulatory Information for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alza EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE brompheniramine maleate; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 019672-001 Mar 29, 1996 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 BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brompheniramine Maleate and Pseudoephedrine Hydrochloride

Introduction

Brompheniramine maleate and pseudoephedrine hydrochloride are commonly used in combination to treat symptoms of the common cold, allergic rhinitis, and other respiratory issues. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

Brompheniramine maleate is a first-generation antihistamine, while pseudoephedrine hydrochloride is a sympathomimetic decongestant. These drugs are often combined with other active ingredients like dextromethorphan to create multi-symptom relief products[5].

Market Size and Growth

The market for cough, cold, and allergy (CCA) medications is substantial and growing, driven by the prevalence of respiratory allergies and the common cold. In 2021, the combination of brompheniramine maleate, dextromethorphan, and pseudoephedrine hydrochloride was the 294th most commonly prescribed medication in the United States, with over 500,000 prescriptions[3].

Competitive Landscape

The CCA market is highly competitive, with numerous brands and generic options available. Key players include pharmaceutical companies like Taro Pharmaceuticals, Poly Pharmaceuticals, and Breckenridge Pharmaceutical, among others. These companies compete through various brand names such as Bromfed, Dimetapp, and Lodrane[1][3].

Regulatory Environment

Regulatory changes can significantly impact the market dynamics of these drugs. For instance, in 2011, the FDA announced the removal of approximately 500 cough/cold and allergy-related products from the US market, including some products manufactured by Elite Pharmaceuticals that contained brompheniramine maleate. This move required manufacturers to stop production and shipping of these products within specified timeframes, affecting revenues for companies involved[2].

Financial Impact

The financial impact of regulatory changes and market competition can be substantial. For example, Elite Pharmaceuticals reported that revenues generated from the affected products totaled $3.02 million for the 9 months ended December 31, 2010, which was a significant portion of their total revenues. The inability to manufacture these drugs could have an adverse effect on their financial performance[2].

Pricing and Revenue

The pricing of brompheniramine maleate and pseudoephedrine hydrochloride products varies based on the formulation, brand, and region. For instance, the cost of brompheniramine maleate powder can range from $9.83 per gram, while liquid formulations can cost around $0.14 to $0.21 per milliliter[1].

Combination Products

Combination products that include brompheniramine maleate, pseudoephedrine hydrochloride, and other active ingredients like dextromethorphan are popular due to their multi-symptom relief benefits. These products are widely prescribed and contribute significantly to the revenue of pharmaceutical companies. For example, the syrup formulation containing these ingredients is indicated for relief of coughs and upper respiratory symptoms, and it is marketed by several companies[5].

Side Effects and Safety Concerns

Both brompheniramine maleate and pseudoephedrine hydrochloride have side effects that can impact their market dynamics. Brompheniramine maleate can cause sedation, dry mouth, and anticholinergic effects, while pseudoephedrine hydrochloride can lead to insomnia, elevated heart rate, and increased blood pressure. These side effects can influence consumer preference and regulatory scrutiny[3][4].

Consumer Preferences and Trends

Consumer preferences are shifting towards over-the-counter (OTC) medications and combination products that offer convenience and comprehensive symptom relief. This trend supports the continued demand for products containing brompheniramine maleate and pseudoephedrine hydrochloride.

Future Outlook

The future outlook for these drugs remains positive due to the ongoing demand for CCA medications. However, pharmaceutical companies must navigate regulatory challenges, competition, and evolving consumer preferences. Innovations in formulation and delivery methods, as well as strategic marketing, will be crucial for maintaining market share.

Key Takeaways

  • Market Size: The CCA market is substantial, with a growing demand for combination products.
  • Regulatory Environment: Regulatory changes can significantly impact product availability and company revenues.
  • Financial Impact: Companies must adapt to regulatory changes to maintain financial stability.
  • Pricing and Revenue: Pricing varies based on formulation and brand, contributing to revenue streams.
  • Combination Products: Multi-symptom relief products are popular and contribute significantly to revenue.
  • Side Effects and Safety Concerns: Side effects influence consumer preference and regulatory scrutiny.
  • Consumer Preferences and Trends: Consumers prefer OTC and combination products for convenience.

FAQs

Q: What are the common brand names for products containing brompheniramine maleate and pseudoephedrine hydrochloride? A: Common brand names include Bromfed, Dimetapp, Bromfenex, and Lodrane[1][3].

Q: What are the primary side effects of brompheniramine maleate and pseudoephedrine hydrochloride? A: Brompheniramine maleate can cause sedation, dry mouth, and anticholinergic effects, while pseudoephedrine hydrochloride can lead to insomnia, elevated heart rate, and increased blood pressure[3][4].

Q: How have regulatory changes impacted the market for these drugs? A: Regulatory changes, such as the FDA's removal of certain products from the market, have required manufacturers to stop production and shipping, affecting company revenues[2].

Q: What is the financial impact of these drugs on pharmaceutical companies? A: These drugs can generate significant revenues for pharmaceutical companies, but regulatory changes and competition can adversely affect financial performance[2].

Q: What are the future trends in the market for these drugs? A: The market is expected to continue growing, driven by demand for CCA medications, with a focus on OTC and combination products offering multi-symptom relief.

References

  1. DrugBank: Brompheniramine - Uses, Interactions, Mechanism of Action.
  2. Biospace: FDA to Remove Two Drugs Manufactured by Elite Pharmaceuticals.
  3. Wikipedia: Brompheniramine.
  4. Wikipedia: Pseudoephedrine.
  5. DailyMed: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE syrup.

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