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Last Updated: December 22, 2024

Acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate - Generic Drug Details


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What are the generic sources for acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate and what is the scope of freedom to operate?

Acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate is the generic ingredient in one branded drug marketed by Schering Plough and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate at DailyMed

US Patents and Regulatory Information for acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering Plough DRIXORAL PLUS acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019453-001 May 22, 1987 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

Acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen; Dexbrompheniramine Maleate; Pseudoephedrine Sulfate

Introduction

The combination of acetaminophen, dexbrompheniramine maleate, and pseudoephedrine sulfate is a multifaceted medication used to treat various symptoms associated with the common cold and seasonal allergies. This article will delve into the market dynamics and financial trajectory of this drug combination, exploring its usage, regulatory environment, market trends, and financial implications.

Components of the Medication

Acetaminophen

Acetaminophen is a widely used pain reliever and antipyretic. It is often combined with other medications to treat a broad range of symptoms, including fever, headaches, and body aches[5].

Dexbrompheniramine Maleate

Dexbrompheniramine is an antihistamine that reduces the effects of histamine in the body, alleviating symptoms such as sneezing, itching, watery eyes, and runny nose[2][3].

Pseudoephedrine Sulfate

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages, relieving nasal congestion and sinus pressure[2][3].

Market Usage and Demand

Common Cold and Allergy Season

The demand for this medication is highly seasonal, peaking during cold and flu seasons as well as during allergy seasons. This seasonal fluctuation can significantly impact sales and revenue[2][3].

Combination Therapies

The combination of acetaminophen, dexbrompheniramine, and pseudoephedrine is popular because it addresses multiple symptoms simultaneously, making it a convenient option for consumers. This multi-symptom relief approach has contributed to its market success[5].

Regulatory Environment

Combat Methamphetamine Epidemic Act of 2005

The purchase of pseudoephedrine-containing products, including this combination medication, has been restricted in the United States due to concerns about its use in the production of methamphetamine. This regulation has impacted the availability and sales of these medications[3].

Removal from Market

In 2008, the brand Drixoral, which contained dexbrompheniramine and pseudoephedrine, was removed from the US market by its manufacturer, Merck, due to supply disruptions and regulatory issues. This removal has affected the market dynamics for similar combination medications[3].

Market Trends

Over-the-Counter (OTC) Market

This medication is primarily available over-the-counter, which makes it easily accessible to consumers. However, the OTC market is highly competitive, with numerous brands and generic options available. This competition can influence pricing and market share[2][5].

Generic and Brand Name Competition

The presence of both generic and brand-name versions of this medication affects market dynamics. Generic versions often offer a cheaper alternative, which can erode the market share of brand-name products. However, brand loyalty and marketing efforts can still maintain a significant market presence for branded products[2].

Financial Trajectory

Revenue Fluctuations

The revenue generated by this medication can fluctuate significantly based on seasonal demand. Peak seasons, such as winter and spring, typically see higher sales, while off-peak seasons result in lower revenue[2][3].

Cost and Pricing

The cost of production and pricing strategies play crucial roles in the financial trajectory. Manufacturers must balance the cost of ingredients, manufacturing, and distribution with competitive pricing to maintain market share. The restrictions on pseudoephedrine have also impacted production costs and pricing due to the need for additional security measures and compliance with regulations[3].

Market Share and Competition

The market share of this medication is influenced by competition from other cold and allergy relief products. Companies must invest in marketing and advertising to maintain or increase their market share. The removal of certain brands from the market, such as Drixoral, has created opportunities for other products to fill the gap[3].

Side Effects and Safety Concerns

Cardiovascular Effects

Pseudoephedrine can have cardiovascular effects, such as slight increases in systolic blood pressure and heart rate, which may be more pronounced in certain individuals. These side effects can impact consumer confidence and sales if not managed properly through clear labeling and consumer education[1].

Other Side Effects

Common side effects include drowsiness, feeling restless or excited, blurred vision, and dry nose or mouth. Severe side effects, such as allergic reactions or uneven heart rates, can also occur. Managing these side effects through proper dosing and consumer advice is crucial for maintaining market trust[2].

Consumer Behavior and Preferences

Convenience and Efficacy

Consumers prefer medications that offer multi-symptom relief, making combination products like this highly appealing. The convenience of a single medication that addresses multiple symptoms is a key driver of consumer choice[5].

Brand Loyalty

Brand loyalty plays a significant role in the market dynamics. Consumers often stick to brands they trust, which can influence sales and revenue. Effective marketing and customer service can enhance brand loyalty[2].

Key Takeaways

  • Seasonal Demand: The demand for this medication is highly seasonal, impacting sales and revenue.
  • Regulatory Environment: Restrictions on pseudoephedrine have affected availability and sales.
  • Market Competition: The OTC market is highly competitive, with both generic and brand-name options influencing market share.
  • Financial Trajectory: Revenue fluctuates with seasonal demand, and production costs are influenced by regulatory compliance.
  • Consumer Preferences: Consumers prefer convenient, multi-symptom relief medications, and brand loyalty is a significant factor.

FAQs

Q: What are the primary components of the medication acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate?

A: The primary components are acetaminophen (a pain reliever and antipyretic), dexbrompheniramine maleate (an antihistamine), and pseudoephedrine sulfate (a decongestant)[2][5].

Q: How does the seasonal demand impact the sales of this medication?

A: The demand peaks during cold and flu seasons as well as during allergy seasons, significantly impacting sales and revenue[2][3].

Q: What regulatory issues have affected this medication?

A: The Combat Methamphetamine Epidemic Act of 2005 restricted the purchase of pseudoephedrine-containing products, and the removal of Drixoral from the US market in 2008 also impacted availability[3].

Q: What are the common side effects of this medication?

A: Common side effects include drowsiness, feeling restless or excited, blurred vision, and dry nose or mouth. Severe side effects can also occur, such as allergic reactions or uneven heart rates[2].

Q: How does consumer behavior influence the market dynamics of this medication?

A: Consumers prefer convenient, multi-symptom relief medications, and brand loyalty is a significant factor in their purchasing decisions[5].

Sources

  1. Wikipedia: Pseudoephedrine
  2. Drugs.com: Dexbrompheniramine and pseudoephedrine
  3. Wikipedia: Dexbrompheniramine/pseudoephedrine
  4. FDA: 022450Orig1s000 - accessdata.fda.gov
  5. Cleveland Clinic: Acetaminophen; Dextromethorphan; Pseudoephedrine Oral Capsules and Tablets

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