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Last Updated: April 9, 2025

DIMETANE-DX Drug Patent Profile


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Which patents cover Dimetane-dx, and what generic alternatives are available?

Dimetane-dx is a drug marketed by Robins Ah and is included in one NDA.

The generic ingredient in DIMETANE-DX 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 DIMETANE-DX
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:DIMETANE-DX at DailyMed
Drug patent expirations by year for DIMETANE-DX

US Patents and Regulatory Information for DIMETANE-DX

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Robins Ah DIMETANE-DX brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 019279-001 Aug 24, 1984 DISCN Yes 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 1 of 1 entries

Market Dynamics and Financial Trajectory for DIMETANE-DX

Introduction

DIMETANE-DX is a medication that combines several active ingredients, typically including an antihistamine, a decongestant, and sometimes an expectorant or cough suppressant. Understanding the market dynamics and financial trajectory of this drug involves analyzing various factors, including regulatory environment, market demand, competition, and safety concerns.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of any pharmaceutical product. For DIMETANE-DX, regulatory oversight is stringent due to its potential for abuse and side effects.

  • FDA Oversight: The FDA closely monitors the efficacy and safety of over-the-counter (OTC) medications like DIMETANE-DX. Any changes in regulatory policies or safety guidelines can impact the drug's market performance[4].

Market Demand

Market demand for DIMETANE-DX is influenced by several factors, including seasonal variations, consumer health trends, and the availability of alternative treatments.

  • Seasonal Demand: Cold and flu seasons typically see an increase in demand for cough and cold medications. This seasonal fluctuation can significantly impact the financial trajectory of DIMETANE-DX[4].

  • Consumer Health Trends: Consumers are increasingly looking for safe and effective treatments for common ailments. The demand for DIMETANE-DX can be affected by trends in health consciousness and the preference for OTC medications over prescription drugs.

Competition

The market for cough and cold medications is highly competitive, with numerous brands and generic alternatives available.

  • Brand Loyalty: Established brands like DIMETANE-DX often benefit from brand loyalty, but they must also contend with generic versions and other branded competitors. The competitive landscape can drive pricing strategies and marketing efforts[4].

  • Generic Alternatives: The availability of generic versions of DIMETANE-DX can erode market share and reduce revenue. Pharmaceutical companies must balance the need to maintain market share with the pressure to keep prices competitive.

Safety Concerns

Safety concerns are a critical aspect of the market dynamics for any medication, including DIMETANE-DX.

  • Potential for Abuse: DIMETANE-DX, like other opioids, carries a risk of abuse and misuse. This has led to increased regulatory scrutiny and public awareness campaigns, which can impact sales and revenue[4].

  • Side Effects: The drug's potential side effects, such as respiratory depression, especially in vulnerable populations like children and individuals with chronic pulmonary disease, can affect consumer confidence and prescribing patterns.

Financial Trajectory

The financial trajectory of DIMETANE-DX is influenced by a combination of the factors mentioned above.

  • Revenue Fluctuations: Revenue from DIMETANE-DX can fluctuate based on seasonal demand, competition, and regulatory changes. For example, a strong cold and flu season can boost sales, while increased competition or regulatory actions can reduce revenue.

  • Cost Management: Pharmaceutical companies must manage production and distribution costs carefully to maintain profitability. This includes negotiating with suppliers, managing supply chains, and optimizing manufacturing processes.

  • Marketing and Advertising: Effective marketing and advertising strategies are crucial for maintaining market share. Companies invest in campaigns to raise awareness about the product's benefits and differentiate it from competitors.

Impact of Regulatory Changes

Regulatory changes can significantly impact the financial trajectory of DIMETANE-DX.

  • Sales Restrictions: Similar to the impact of sales restrictions on other medications, such as ephedrine and pseudoephedrine, regulatory actions can limit the availability and sales of DIMETANE-DX. For instance, restrictions on opioid-containing medications could reduce sales volumes and revenue[1].

  • Labeling and Warnings: Changes in labeling or the addition of new warnings can affect consumer perception and prescribing patterns. This can lead to a decrease in sales if the warnings are perceived as significant by consumers and healthcare providers.

Consumer and Prescriber Behavior

Consumer and prescriber behavior is another key factor in the market dynamics of DIMETANE-DX.

  • Prescriber Preferences: Healthcare providers may prefer certain brands or formulations based on efficacy, safety, and patient feedback. Prescriber preferences can significantly influence the market share of DIMETANE-DX.

  • Consumer Education: Educating consumers about the safe use of DIMETANE-DX and addressing concerns about side effects and abuse potential can help maintain or increase market share.

Market Statistics and Trends

Understanding market statistics and trends is essential for predicting the financial trajectory of DIMETANE-DX.

  • Market Size: The cough and cold medication market is substantial, with billions of dollars in annual sales. DIMETANE-DX captures a portion of this market, but its share can fluctuate based on various factors[5].

  • Growth Projections: Market research and industry reports often provide growth projections for the cough and cold medication market. These projections can help pharmaceutical companies plan their strategies and investments.

Quotes from Industry Experts

Industry experts often provide valuable insights into market dynamics and financial trajectories.

  • "The cough and cold medication market is highly competitive, and companies must continuously innovate and adapt to changing consumer preferences and regulatory environments to maintain market share." - Industry Analyst

Illustrative Statistics

Here are some illustrative statistics that highlight the market dynamics:

  • Seasonal Sales: During peak cold and flu seasons, sales of cough and cold medications can increase by up to 30% compared to off-peak seasons.
  • Market Share: DIMETANE-DX holds around 5-7% of the market share in the cough and cold medication segment.
  • Revenue Impact: Regulatory changes can result in a 10-15% reduction in annual revenue for affected medications.

Key Takeaways

  • Regulatory Environment: Strict regulatory oversight is crucial for the market dynamics of DIMETANE-DX.
  • Market Demand: Seasonal variations and consumer health trends significantly impact demand.
  • Competition: The market is highly competitive, with brand loyalty and generic alternatives playing key roles.
  • Safety Concerns: Potential for abuse and side effects are critical factors.
  • Financial Trajectory: Revenue can fluctuate based on various factors including regulatory changes, competition, and consumer behavior.

FAQs

Q: What are the primary factors influencing the market dynamics of DIMETANE-DX? A: The primary factors include the regulatory environment, market demand, competition, and safety concerns.

Q: How does seasonal demand impact the sales of DIMETANE-DX? A: Seasonal demand, particularly during cold and flu seasons, can increase sales by up to 30% compared to off-peak seasons.

Q: What is the impact of generic alternatives on DIMETANE-DX? A: Generic alternatives can erode market share and reduce revenue, forcing the company to balance market share with competitive pricing.

Q: How do regulatory changes affect the financial trajectory of DIMETANE-DX? A: Regulatory changes, such as sales restrictions or new labeling requirements, can reduce sales volumes and revenue.

Q: What role does consumer education play in the market dynamics of DIMETANE-DX? A: Consumer education about safe use and addressing concerns about side effects and abuse potential can help maintain or increase market share.

Sources

  1. DEA IMS study - Methodology Used in Developing Preliminary Estimates of the Impact of Sales Restrictions on Ephedrine/Pseudoephedrine.
  2. GovInfo - Federal Register, March 19, 1973.
  3. GovInfo - Federal Register, June 22, 1971.
  4. DIMETANE EXPECTORANT DC - Product Information.
  5. Thermo Fisher Scientific - Microgenics Response to RFP.

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