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Last Updated: April 16, 2025

POLARAMINE Drug Patent Profile


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

Polaramine is a drug marketed by Schering and is included in two NDAs.

The generic ingredient in POLARAMINE is dexchlorpheniramine maleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.

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Summary for POLARAMINE
Drug patent expirations by year for POLARAMINE
Recent Clinical Trials for POLARAMINE

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SponsorPhase
University Hospital, BordeauxPhase 3

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US Patents and Regulatory Information for POLARAMINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Schering POLARAMINE dexchlorpheniramine maleate TABLET;ORAL 086835-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Schering POLARAMINE dexchlorpheniramine maleate SYRUP;ORAL 086837-001 Jul 19, 1982 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 Polaramine (Dexchlorpheniramine)

Introduction to Polaramine

Polaramine, also known as dexchlorpheniramine, is an antihistamine with anticholinergic properties, widely used to treat allergic conditions such as hay fever or urticaria. It is the pharmacologically active dextrorotatory isomer of chlorpheniramine.

Global Market Size and Growth

The global market for dexchlorpheniramine was valued at US$ 4631 million in 2023. This market is forecasted to grow to a readjusted size of US$ 6289.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period of 2024-2030[4].

Market Segmentation

The market for dexchlorpheniramine is segmented by region, type, and application. Here are some key segments:

Regional Segmentation

The market is analyzed across various regions including North America, Europe, Asia Pacific, and South America. Each region's sales value and volume are forecasted from 2019 to 2030, providing a comprehensive view of the market's geographical distribution[4].

Type and Application Segmentation

While the report does not delve deeply into type and application segments, it is crucial to note that the demand for dexchlorpheniramine can vary based on the specific allergic conditions it treats and the formulations available (e.g., tablets, syrups, or injectables).

Key Drivers and Trends

Several factors drive the growth of the dexchlorpheniramine market:

Increasing Prevalence of Allergic Conditions

The rising incidence of allergic conditions such as hay fever and urticaria contributes significantly to the demand for antihistamines like dexchlorpheniramine.

COVID-19 Pandemic Impact

The COVID-19 pandemic has highlighted the importance of robust healthcare systems and the need for effective management of allergic reactions, which has indirectly boosted the demand for antihistamines[4].

Advancements in Pharmaceutical Technology

Continuous advancements in pharmaceutical technology, including the development of more effective and safer formulations, also drive market growth.

Competitive Landscape

The market for dexchlorpheniramine is highly competitive, with several major pharmaceutical companies involved:

Key Companies

Companies such as LETI, Novartis, Hypera Pharma, Woodward, Merck, Johnson and Johnson, Ethical Pharma, and others are significant players in the global dexchlorpheniramine market. These companies compete based on factors such as product quality, pricing, and market reach[4].

Financial Performance and Projections

The financial trajectory of the dexchlorpheniramine market is promising:

Revenue Growth

The market revenue is expected to increase from US$ 4631 million in 2023 to US$ 6289.9 million by 2030, indicating a steady growth trend.

CAGR

A CAGR of 4.5% during the forecast period of 2024-2030 suggests a moderate but consistent growth rate[4].

Regional Market Analysis

The market performance varies by region:

North America

North America, including the U.S., Canada, and Mexico, is a significant market for dexchlorpheniramine due to high healthcare spending and a large patient base.

Europe

Europe, with countries like Germany, France, and the UK, also represents a substantial market share due to its well-developed healthcare infrastructure.

Asia Pacific

The Asia Pacific region, including China, Japan, and India, is expected to show rapid growth due to increasing healthcare awareness and spending[4].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces several challenges and opportunities:

Regulatory Environment

Stringent regulatory requirements can pose challenges for new entrants and existing players. However, compliance with these regulations can also ensure product safety and efficacy, which is a significant opportunity.

Generic Competition

The presence of generic versions of dexchlorpheniramine can reduce the market share of branded products but also increases accessibility and affordability for patients.

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics:

Preference for Over-the-Counter (OTC) Medications

Consumers increasingly prefer OTC medications for minor allergic conditions, which can drive the demand for dexchlorpheniramine. This trend is similar to the broader OTC drugs market, where consumers favor easily accessible, non-prescription treatment options[1].

Impact of Economic Factors

Economic factors such as healthcare spending and insurance coverage also influence the market:

Healthcare Spending

Increased healthcare spending, particularly in regions with growing economies, can boost the demand for pharmaceutical products like dexchlorpheniramine.

Insurance Coverage

Changes in insurance coverage policies, such as those introduced by the Inflation Reduction Act in the U.S., can affect out-of-pocket spending and thus influence the market dynamics[3].

Key Takeaways

  • The global dexchlorpheniramine market is projected to grow from US$ 4631 million in 2023 to US$ 6289.9 million by 2030.
  • The market is driven by increasing prevalence of allergic conditions, advancements in pharmaceutical technology, and the impact of the COVID-19 pandemic.
  • Key companies include LETI, Novartis, Hypera Pharma, and others, competing on product quality, pricing, and market reach.
  • Regional markets such as North America, Europe, and Asia Pacific are significant, with Asia Pacific expected to show rapid growth.
  • Challenges include regulatory environments and generic competition, while opportunities lie in compliance with regulations and increased accessibility.

FAQs

1. What is dexchlorpheniramine used for?

Dexchlorpheniramine, also known as Polaramine, is used to treat allergic conditions such as hay fever or urticaria.

2. What is the projected market size of dexchlorpheniramine by 2030?

The global market for dexchlorpheniramine is forecasted to reach US$ 6289.9 million by 2030[4].

3. What is the CAGR of the dexchlorpheniramine market from 2024 to 2030?

The market is expected to grow at a CAGR of 4.5% during the forecast period of 2024-2030[4].

4. Which regions are significant for the dexchlorpheniramine market?

North America, Europe, and Asia Pacific are significant regions for the dexchlorpheniramine market, with Asia Pacific expected to show rapid growth[4].

5. What are the key challenges facing the dexchlorpheniramine market?

Key challenges include stringent regulatory requirements and competition from generic versions of the drug.

Cited Sources:

  1. Over The Counter Drugs [OTC] Market Size & Growth Report, 2032 - SNS Insider
  2. Integrated Report - Laboratorios Farmaceuticos ROVI - ROVI
  3. Recent and Forecasted Trends in Prescription Drug Spending - Health System Tracker
  4. Dexchlorpheniramine - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030 - QY Research

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