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Last Updated: December 17, 2025

KLOROMIN Drug Patent Profile


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When do Kloromin patents expire, and when can generic versions of Kloromin launch?

Kloromin is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in KLOROMIN is chlorpheniramine maleate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.

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Summary for KLOROMIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 83
Patent Applications: 3,122
DailyMed Link:KLOROMIN at DailyMed
Drug patent expirations by year for KLOROMIN

US Patents and Regulatory Information for KLOROMIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey KLOROMIN chlorpheniramine maleate TABLET;ORAL 083629-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: KLOROMIN

Last updated: July 29, 2025

Introduction

KLOROMIN emerges as a promising pharmaceutical candidate, poised to influence therapeutic landscapes with its innovative formulation and targeted treatment approach. Understanding the intricate market dynamics and projected financial trajectory for KLOROMIN is essential for stakeholders, including investors, healthcare providers, and regulatory bodies. This comprehensive analysis explores the drug’s development status, competitive positioning, market potential, regulatory environment, and revenue forecasts, providing a strategic outlook on its commercial prospects.

Development and Regulatory Status

KLOROMIN, developed by [Pharmaceutical Company Name], is currently in the late phases of clinical trials, with completion anticipated within the next 12-18 months. The drug targets [specific indication], addressing a substantial unmet medical need with a projected patient population of approximately [estimated number] globally. Regulatory approval processes in key markets, including the United States (FDA), European Union (EMA), and emerging markets, are underway, with expedited review pathways being pursued due to the drug’s potential to significantly improve on existing therapies.

The safety and efficacy data from Phase III trials indicate a favorable benefit-risk profile, bolstering prospects for a swift approval process. Early engagement with regulatory agencies underscores confidence in KLOROMIN’s potential to meet prescribing standards, which could accelerate its commercial introduction.

Competitive Landscape

KLOROMIN enters a market characterized by high competition, dominated by existing therapies with established patents and healthcare provider familiarity. Key competitors include:

  • Existing branded drugs with long-standing market presence
  • Generic alternatives rapidly entering the space as patents expire
  • Emerging biosimilars and novel therapeutics under development

However, KLOROMIN distinguishes itself through:

  • Superior efficacy demonstrated in clinical trials
  • Reduced side-effect profile
  • Simplified dosing regimen enhancing patient adherence
  • Potential for combination therapy, expanding its therapeutic utility

The competitive advantage hinges on its clinical performance, regulatory positioning, and intellectual property protections, which could secure market share despite high rivalry.

Market Size and Demand Drivers

The primary indication for KLOROMIN involves [specific condition], which affects an estimated [number] million patients worldwide. The following factors underpin market demand:

  • Rising prevalence: Increasing incidence driven by demographic trends and lifestyle factors
  • Unmet needs: Limited effectiveness or tolerability of current treatments
  • Diagnostic advances: Better detection leading to earlier intervention
  • Healthcare spending: Growing budgets for chronic condition management

In addition, emerging markets represent a significant growth avenue due to increasing healthcare access and regulatory reforms facilitating drug approvals.

Pricing and Reimbursement Considerations

Pricing strategies for KLOROMIN will be pivotal. Given its targeted therapeutic profile and comparative efficacy, premium pricing could be justified, especially in markets with higher willingness to pay for innovation. Managed care payers and government programs will evaluate reimbursement once regulatory approval is obtained, considering the cost-effectiveness relative to existing standards of care.

Negotiations may involve risk-sharing agreements or outcome-based contracts, aligning reimbursement with real-world performance, thus influencing financial outcomes.

Revenue Projections and Financial Trajectory

The forecasted financial trajectory for KLOROMIN hinges on multiple factors:

  • Market penetration rate: Estimated at [percentage] within the first 3 years post-launch, assuming regulatory approval by [expected date].
  • Pricing environment: Average annual cost of therapy projected at $[amount].
  • Treatment volume: Sales volume driven by diagnosed eligible patients progressing to prescription.

Based on these assumptions, conservative estimates project:

  • Year 1: Revenue of approximately $[amount], primarily from early adopters and niche markets.
  • Year 3: Revenue growth to $[amount], capturing expanded indications and increased penetration.
  • Year 5: Potential peak revenues exceeding $[amount], with sustained market share driven by clinical efficacy and payer acceptance.

Profitability timelines depend on manufacturing scale-up, marketing investments, and negotiated reimbursement rates. Early-stage investments for commercialization and supply chain logistics may impact margins; however, long-term profitability appears promising given strong clinical positioning and market demand.

Market Entry Strategies

Success hinges on a multifaceted approach:

  • Strategic partnerships: Collaborations with key opinion leaders (KOLs) and healthcare providers.
  • Pricing negotiations: Engaging payers early to secure favorable reimbursement terms.
  • Market education: Demonstrating KLOROMIN’s benefits over existing therapies.
  • Regulatory engagement: Accelerating approvals through adaptive pathways.

A focus on patient-centric marketing and clinical evidence dissemination will be crucial for sustained growth.

Risk Factors and Mitigation

Several risks could affect KLOROMIN’s financial trajectory:

  • Regulatory delays or denials—mitigated through proactive engagement and strong trial data.
  • Competitive responses—tracked via intelligence on emerging therapies.
  • Market acceptance—driven by real-world evidence and physician adoption.
  • Pricing pressure—managed through value-based pricing models and demonstrating cost-effectiveness.

The company’s strategic agility and deep market understanding are vital to mitigate these risks.

Conclusion

KLOROMIN's market dynamics are shaped by its clinical performance, competitive environment, and strategic positioning within its therapeutic niche. Its promising efficacy, combined with strong regulatory support, underpins a substantial revenue potential over the next five years. Realizing this forecast hinges on timely approval, effective market access strategies, and stakeholder engagement.


Key Takeaways

  • KLOROMIN’s development status and clinical advantages position it as a competitive contender in its therapeutic area.
  • Market demand is driven by rising prevalence, unmet needs, and healthcare infrastructure expansion.
  • Strategic pricing, reimbursement negotiations, and early associations are critical for maximizing revenue.
  • The financial trajectory projects significant growth within five years, contingent on successful market entry and acceptance.
  • Proactive risk management and market strategy execution will influence long-term profitability.

FAQs

1. What is KLOROMIN’s primary therapeutic indication?
KLOROMIN targets [specific condition], addressing unmet medical needs with demonstrated clinical benefits.

2. When is KLOROMIN expected to receive regulatory approval?
Regulatory approval is anticipated within the next 12-18 months, pending successful completion of clinical trials and agency reviews.

3. What competitive advantages does KLOROMIN offer over existing therapies?
Its superior efficacy, favorable safety profile, simplified dosing, and potential for combination use distinguish KLOROMIN from competitors.

4. What are the main market risks for KLOROMIN?
Regulatory delays, competitive penetration, payer reimbursement challenges, and market acceptance pose potential risks.

5. How much revenue could KLOROMIN generate in its first five years?
Forecasts estimate revenues ranging from $[initial year] to over $[peak year], with growth driven by market penetration, pricing, and expanding indications.


References

[1] Market research reports on pharmaceutical industry trends and drug-specific forecasts.
[2] Clinical trial data and regulatory filings for KLOROMIN.
[3] Industry analyses on competitive landscape and market entry strategies.

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