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Last Updated: April 13, 2025

BROMFED-DM Drug Patent Profile


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When do Bromfed-dm patents expire, and what generic alternatives are available?

Bromfed-dm is a drug marketed by Wockhardt and Xttrium Labs Inc and is included in two NDAs.

The generic ingredient in BROMFED-DM is brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride profile page.

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Summary for BROMFED-DM
US Patents:0
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
DailyMed Link:BROMFED-DM at DailyMed
Drug patent expirations by year for BROMFED-DM

US Patents and Regulatory Information for BROMFED-DM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Xttrium Labs Inc BROMFED-DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088811-001 Jun 7, 1985 AA RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Wockhardt BROMFED-DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 089681-001 Dec 22, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for BROMFED-DM

Introduction

BROMFED-DM is a prescription medication used to treat cough and nasal congestion, combining the effects of an antihistamine (brompheniramine), a sympathomimetic (pseudoephedrine), and an antitussive (dextromethorphan). Understanding the market dynamics and financial trajectory of this drug involves analyzing various factors, including its pharmacological profile, market demand, regulatory environment, and competitive landscape.

Pharmacological Profile and Indications

BROMFED-DM is formulated as an oral syrup, containing 2mg of brompheniramine maleate, 30mg of pseudoephedrine hydrochloride, and 10mg of dextromethorphan hydrobromide per 5mL dose. It is indicated for the relief of cough and nasal congestion associated with upper respiratory tract infections[2][4][5].

Market Demand

The demand for BROMFED-DM is driven by the prevalence of upper respiratory infections, which are common and recurring. This demand is consistent across various age groups, although the dosage and administration vary based on age. For instance, adults and children over 12 years can take 10mL every 4 hours, while younger children require adjusted doses[4][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of any pharmaceutical product. BROMFED-DM, being a prescription drug, is subject to strict regulatory oversight. It must comply with FDA guidelines and is contraindicated in certain conditions such as asthma, severe hypertension, and within 14 days of MAOIs[2][4].

Competitive Landscape

The market for upper respiratory combination drugs is competitive, with several other products available that offer similar therapeutic benefits. BROMFED-DM competes with other antihistamine-sympathomimetic-antitussive combinations, and its market share is influenced by factors such as pricing, brand recognition, and the prescribing habits of healthcare professionals.

Financial Trajectory

Revenue Streams

The revenue generated by BROMFED-DM comes primarily from prescription sales. The financial performance can be gauged by looking at the sales volume and the pricing strategy. Given that it is a prescription-only medication, its sales are influenced by healthcare insurance coverage and reimbursement policies.

Cost and Pricing

The cost of BROMFED-DM can vary based on the region, insurance coverage, and the specific formulation. Generally, the pricing is competitive with other similar medications on the market. The cost-effectiveness of the drug, compared to other treatments for upper respiratory infections, also plays a role in its financial trajectory.

Growth Trends

The growth of BROMFED-DM sales can be influenced by several factors, including the prevalence of upper respiratory infections, changes in prescribing patterns, and the introduction of new competitors or generic alternatives. Historical data on prescription drug expenditures shows that such medications can experience significant growth, driven by increased usage and higher costs per treatment[3].

Impact of Sales Restrictions

In the context of other medications containing pseudoephedrine, sales restrictions can significantly impact the financial trajectory. For example, restrictions on the sale of pseudoephedrine-containing products due to their potential use in methamphetamine production have led to declines in sales volumes in the past[1].

Demographic Factors

Demographic changes, such as an aging population, can also influence the financial trajectory of BROMFED-DM. Older adults may require more frequent or prolonged use of such medications, which can drive up demand and revenue. However, this demographic may also experience more adverse reactions, which could affect prescribing habits and thus impact sales[3][4].

Clinical Trials and Research

While BROMFED-DM itself may not be undergoing new clinical trials, ongoing research in the field of upper respiratory infections and new therapeutic approaches can influence its market position. Advances in treatment options or changes in clinical guidelines can either boost or diminish the demand for this medication.

Adverse Reactions and Safety Profile

The safety profile of BROMFED-DM, including its potential for adverse reactions such as sedation, dizziness, and anticholinergic effects, can impact its financial trajectory. Adverse reactions can lead to reduced prescribing rates and lower patient compliance, affecting overall sales[2][4].

Patient Counseling and Education

Effective patient counseling and education on the proper use of BROMFED-DM can enhance patient compliance and safety, thereby supporting its financial performance. This includes informing patients about potential interactions with other medications and the importance of adhering to the prescribed dosage[4].

Key Takeaways

  • Market Demand: Driven by the prevalence of upper respiratory infections.
  • Regulatory Environment: Subject to FDA guidelines and specific contraindications.
  • Competitive Landscape: Competes with other antihistamine-sympathomimetic-antitussive combinations.
  • Financial Trajectory: Influenced by sales volume, pricing, insurance coverage, and demographic factors.
  • Safety Profile: Adverse reactions can impact prescribing rates and patient compliance.
  • Patient Education: Crucial for enhancing compliance and safety.

Frequently Asked Questions

1. What are the primary indications for BROMFED-DM?

BROMFED-DM is indicated for the relief of cough and nasal congestion associated with upper respiratory tract infections.

2. How does the regulatory environment impact BROMFED-DM?

BROMFED-DM must comply with FDA guidelines and is subject to specific contraindications, which can affect its market availability and usage.

3. What are the potential adverse reactions to BROMFED-DM?

Common adverse reactions include sedation, dizziness, anticholinergic effects, and thickening of bronchial secretions.

4. How does demographic change influence the demand for BROMFED-DM?

An aging population may drive up demand due to increased usage, but may also experience more adverse reactions, affecting prescribing habits.

5. What factors influence the financial trajectory of BROMFED-DM?

Factors include sales volume, pricing, insurance coverage, demographic changes, and the introduction of new competitors or generic alternatives.

Cited Sources:

  1. DEA IMS study - Methodology Used in Developing Preliminary Estimates of Ephedrine and Pseudoephedrine Usage.
  2. BROMFED-DM Dosage & Rx Info - Uses, Side Effects.
  3. Booming prescription drug expenditure - A population-based study.
  4. Bromfed DM: Package Insert / Prescribing Information - Drugs.com.
  5. Bromfed DM Dosage Guide - Drugs.com.

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