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Last Updated: April 27, 2025

Drug Price Trends for NDC 76282-0756


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Market Analysis and Price Projections for Dofetilide (NDC 76282-0756)

Dofetilide, a class III antiarrhythmic agent marketed under NDC 76282-0756 by Exelan Pharmaceuticals, Inc., is a critical therapeutic option for managing atrial fibrillation and atrial flutter. This report provides a comprehensive analysis of the current market landscape, growth drivers, regional dynamics, competitive environment, and price projections for Dofetilide, synthesizing data from industry reports, regulatory filings, and pricing databases.


Global Market Overview

Current Market Size and Growth Trajectory

The global Dofetilide market has demonstrated steady growth, driven by the increasing prevalence of cardiac arrhythmias and advancements in cardiovascular care. In 2024, the market was valued at approximately $350 million, with projections suggesting a compound annual growth rate (CAGR) of 5.5%–8.7% through 2033[10][12]. By 2030, the market is expected to reach between $1.2 billion and $1.5 billion, contingent on regional healthcare policies and adoption rates of generic formulations[12][15]. The Asia-Pacific region is anticipated to witness the fastest growth, fueled by rising healthcare investments and an aging population[10][12].

Key Market Drivers

  1. Increasing Prevalence of Atrial Fibrillation:
    Atrial fibrillation (AF) affects over 33 million individuals globally, with its incidence rising due to aging populations and lifestyle factors[9][10]. Dofetilide’s efficacy in maintaining sinus rhythm positions it as a first-line therapy, particularly in patients with structural heart disease[9].
  2. Generic Drug Penetration:
    The expiration of brand-name patents has enabled widespread availability of generic Dofetilide, reducing treatment costs by 20–40% compared to branded alternatives[14][16]. This shift has expanded access in emerging markets, where cost sensitivity is high[10].
  3. Technological and Regulatory Advancements:
    Recent FDA approvals for sustained-release formulations and combination therapies have enhanced patient compliance and therapeutic outcomes[12]. Additionally, regulatory initiatives like the Medicare Drug Price Negotiation Program aim to further reduce out-of-pocket expenses, though Dofetilide is not yet included[14].

Pricing Dynamics and Cost Analysis

Current Pricing Structure

As of 2025, the average cash price for Dofetilide in the U.S. ranges from $0.27 to $2.92 per capsule, depending on dosage (125 mcg, 250 mcg, or 500 mcg)[16]. A 60-capsule supply typically costs between $16 and $175, with significant variation across pharmacies and insurance plans[16]. Generic competition has stabilized prices, though regional disparities persist due to taxation and supply chain inefficiencies[14][18].

Factors Influencing Future Pricing

  • Inflation and Production Costs:
    Drug price inflation, projected at 3.81% annually, may modestly increase Dofetilide’s cost, though generic competition will mitigate upward pressure[14].
  • Policy Interventions:
    Expanding Medicare negotiation to include antiarrhythmics could reduce prices by 10–15% in the U.S., mirroring trends observed in other therapeutic classes[14][18].
  • Global Supply Chain Dynamics:
    Geopolitical disruptions and raw material shortages remain risks, potentially elevating manufacturing costs by 5–8% in the short term[12][15].

Regional Market Insights

North America: Dominance and Challenges

North America accounts for 40–45% of global Dofetilide sales, driven by advanced healthcare infrastructure and high AF diagnosis rates[10][12]. However, stringent regulatory oversight and pricing transparency laws are pressuring manufacturers to justify cost structures[14][18].

Europe: Steady Growth with Regulatory Hurdles

Europe holds 25–30% market share, with Germany and France leading in adoption due to robust public healthcare systems[12]. The European Medicines Agency’s (EMA) emphasis on post-marketing surveillance has increased compliance costs, slowing profit margins for generic producers[12].

Asia-Pacific: Emerging Opportunities

The Asia-Pacific region is projected to grow at a CAGR of 7.5–8.5%, driven by India and China’s expanding middle class and improving access to cardiac care[10][12]. Local production of generics has reduced prices by 30–50% compared to imported brands, enhancing affordability[10].


Competitive Landscape

Key Players and Strategies

The Dofetilide market is dominated by generic manufacturers, including Mayne Pharma, Sigmapharm Laboratories, and Sun Pharmaceutical Industries[10][12]. Strategic initiatives include:

  • Partnerships for Distribution:
    Collaborations between Western pharmaceutical firms and Asian distributors aim to penetrate rural markets[12].
  • Investment in Formulation Innovation:
    Extended-release capsules and patient-centric packaging (e.g., blister packs with dosage reminders) are differentiating products in competitive markets[12].

Market Consolidation Trends

Mergers and acquisitions (M&A) activity remains limited due to the niche nature of antiarrhythmic markets. However, vertical integration by companies like Pfizer into raw material production has reduced supply chain vulnerabilities[12][15].


Future Projections and Challenges

Market Growth Forecasts

By 2030, the Dofetilide market is expected to reach $1.5 billion, assuming a CAGR of 6.8%[12]. This growth will be underpinned by:

  • Expansion of telemedicine platforms improving diagnosis rates in underserved regions[10].
  • Integration of AI-driven predictive analytics to optimize dosing and reduce adverse events[10].

Potential Risks

  • Regulatory Scrutiny:
    Heightened focus on opioid overprescription may inadvertently restrict access to antiarrhythmics due to overlapping monitoring requirements[18].
  • Emerging Therapeutic Alternatives:
    Catheter ablation and implantable cardioverter-defibrillators (ICDs) are gaining traction, potentially reducing reliance on pharmacological treatments[9][12].

Conclusion

The Dofetilide market is poised for sustained growth, shaped by demographic trends, generic penetration, and regulatory developments. While pricing pressures will persist, strategic investments in innovation and emerging markets offer pathways for revenue diversification. Stakeholders must navigate regulatory complexities and competitive dynamics to capitalize on opportunities in this evolving landscape.

“The future of antiarrhythmic therapy lies in balancing affordability with precision medicine.” [10][12]

References

  1. https://www.findacode.com/ndc/labelers/Exelan_Pharmaceuticals,_Inc.--76282
  2. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4aad4d30-3e18-489c-80ad-ccf7532bb933
  3. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3fdc6e94-2504-416c-81dd-2db9bc194ebb
  4. https://fda.report/NDC/76282-422
  5. https://www.emergenresearch.com/industry-report/pharmacogenomics-market
  6. https://www.thebusinessresearchcompany.com/report/narcotic-drugs-global-market-report
  7. https://fda.report/NDC/76282-212
  8. https://www.brickeconomy.com/set/76282-1/lego-guardians-of-the-galaxy-rocket-baby-groot
  9. https://www.datainsightsmarket.com/reports/dofetilide-1175626
  10. https://www.verifiedmarketreports.com/product/dofetilide-market/
  11. https://www.marketresearchintellect.com/product/global-dofetilide-market/
  12. https://marketpublishers.com/r/D72F17EDF913EN.html
  13. https://www.marketresearchintellect.com/product/dofetilide-market/
  14. https://www.drugpatentwatch.com/p/drug-price/ndc/59651-0118
  15. https://www.globalmarketvision.com/reports/global-dofetilide-market/285709
  16. https://www.drugs.com/price-guide/dofetilide
  17. https://www.cebt.org/files/0e525defb/CVS+Caremark_CEBT+Vail+Deck+7_15.pdf
  18. https://aspe.hhs.gov/sites/default/files/documents/20e14b66420440b9e726c61d281cc5a5/cost-of-generic-drugs-erg.pdf
  19. https://coincodex.com/stock/EXC/price-prediction/

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