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Last Updated: December 22, 2024

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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

Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride is the generic ingredient in four branded drugs marketed by Alpharma Us Pharms, Wockhardt, Wockhardt Bio Ag, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Pharm Assoc, Rhodes Pharms, Taro, Wes Pharma Inc, and Robins Ah, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Pharmacology for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Robins Ah DIMETANE-DX brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 019279-001 Aug 24, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Acella BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 203375-001 Sep 20, 2016 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wes Pharma Inc BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 211170-001 Jun 16, 2020 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 210647-001 Jul 14, 2020 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alpharma Us Pharms BROMANATE DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088722-001 Mar 7, 1985 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

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Brompheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride

Introduction

Brompheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride are key components of several over-the-counter (OTC) and prescription medications used to treat symptoms associated with allergies, the common cold, and upper respiratory infections. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The market for these combination drugs is driven by the high prevalence of allergic rhinitis, common colds, and other upper respiratory conditions. These medications are widely available in various formulations, including syrups, tablets, and elixirs, making them accessible to a broad patient population[2][4][5].

Demand and Consumption Patterns

The demand for these drugs is consistent throughout the year but tends to peak during seasonal allergy periods and flu seasons. Consumers often seek relief from symptoms such as coughs, nasal congestion, and sneezing, which are effectively managed by these combination products[2][4].

Competitive Landscape

The market is competitive, with multiple brands and generic versions available. Brands like Bromfed DM, Lodrane D, and Alahist DM, among others, compete for market share. Generic versions also play a significant role, offering cost-effective alternatives to branded products[1][3][5].

Pricing and Revenue

The pricing of these medications varies based on the formulation, brand, and region. For instance, the cost of Bromfed DM syrup can range from $0.21 to $0.14 per mL, depending on the manufacturer and location[1]. The revenue generated from these drugs is substantial, given their widespread use and the large patient population they serve.

Regulatory Environment

These drugs are generally classified as OTC or prescription medications, depending on the specific combination and dosage. They are regulated by health authorities such as the FDA, which ensures their safety and efficacy. The absence of DEA scheduling for these drugs indicates they are not controlled substances, which can influence their market availability and accessibility[2][4].

Dosage and Administration

The dosage and administration guidelines for these combination products are well-defined. For example, Bromfed DM is typically administered as 2.5 mL orally every 4 hours as needed, with a maximum of 15 mL per day for children and 80 mL per day for adults[3]. Adherence to these guidelines is crucial for both efficacy and safety.

Side Effects and Safety Profile

While generally safe, these medications can have side effects such as sedation, dryness of the mouth, nose, and throat, and thickening of bronchial secretions. Other adverse reactions may include dermatologic, cardiovascular, and CNS effects. The safety profile is a critical factor in market dynamics, as it influences consumer trust and regulatory approval[4].

Pregnancy and Lactation Considerations

The use of these medications during pregnancy and lactation is approached with caution. Animal studies have shown potential risks, and human studies are limited. As a result, healthcare professionals advise pregnant or breastfeeding patients to use these drugs only if the benefits outweigh the risks[4][5].

Financial Performance

The financial performance of these drugs is robust due to their widespread use and the recurring nature of the conditions they treat. Pharmaceutical companies that manufacture these products often report significant revenues from these lines. For instance, the market for cold and allergy medications is a multi-billion dollar industry, with these combination products being a substantial part of it.

Future Outlook

The future outlook for these drugs remains positive, driven by the ongoing demand for effective treatments for allergic and respiratory conditions. Advances in formulation technology and the development of new combination products are expected to further enhance market growth. Additionally, the increasing awareness of self-care and the preference for OTC medications are likely to sustain the financial trajectory of these drugs.

Key Takeaways

  • Consistent Demand: The demand for these medications is consistent, with peaks during allergy and flu seasons.
  • Competitive Market: Multiple brands and generic versions compete in the market.
  • Regulatory Compliance: These drugs are regulated by health authorities to ensure safety and efficacy.
  • Safety Profile: While generally safe, they can have side effects that influence market dynamics.
  • Financial Performance: The financial performance is robust due to widespread use and recurring conditions.
  • Future Outlook: The market is expected to grow driven by ongoing demand and advances in formulation technology.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of brompheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride?

A: These medications are used to treat symptoms associated with allergies, the common cold, and upper respiratory infections, including coughs, nasal congestion, and sneezing.

Q: How are these medications typically administered?

A: They are usually administered orally in the form of syrups, tablets, or elixirs, with specific dosages and administration guidelines provided for different age groups.

Q: What are the common side effects of these medications?

A: Common side effects include sedation, dryness of the mouth, nose, and throat, and thickening of bronchial secretions. Other adverse reactions can include dermatologic, cardiovascular, and CNS effects.

Q: Can these medications be used during pregnancy and lactation?

A: These medications should be used with caution during pregnancy and lactation, as animal studies have shown potential risks and human studies are limited.

Q: What is the competitive landscape like for these medications?

A: The market is competitive, with multiple branded and generic versions available, offering consumers a range of choices.

Sources:

  1. DrugBank: Brompheniramine - Uses, Interactions, Mechanism of Action
  2. DailyMed: BROMFED DM - brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup
  3. PDR.net: Bromfed-DM - Drug Summary
  4. DailyMed: brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup
  5. RxList: Brompheniramine/Dextromethorphan/Pseudoephedrine - Generic Drug

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