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Drug Price Trends for NDC 76282-0755
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Average Pharmacy Cost for 76282-0755
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DOFETILIDE 125 MCG CAPSULE | 76282-0755-60 | 0.23595 | EACH | 2025-04-23 |
| DOFETILIDE 125 MCG CAPSULE | 76282-0755-60 | 0.24250 | EACH | 2025-04-09 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 76282-0755
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| No data available in table | |||||||
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Dofetilide (NDC 76282-0755)
Dofetilide, a class III antiarrhythmic agent marketed under the brand name Tikosyn, is a critical therapeutic option for managing atrial fibrillation and atrial flutter. The drug, identified by the National Drug Code (NDC) 76282-0755 and manufactured by Exelan Pharmaceuticals, Inc., has garnered significant attention in cardiovascular pharmacotherapy due to its efficacy in rhythm control. This report provides a comprehensive analysis of the dofetilide market, including growth drivers, competitive dynamics, regulatory considerations, and price projections through 2035.
Overview of Dofetilide and Its Therapeutic Role
Dofetilide functions as a potassium channel blocker, stabilizing cardiac repolarization to prevent life-threatening arrhythmias. Its primary indications include:
- Conversion of persistent atrial fibrillation to sinus rhythm.
- Maintenance of sinus rhythm post-cardioversion[14].
Despite its niche application, dofetilide occupies a unique position in cardiology due to its safety profile in patients with left ventricular dysfunction, as evidenced by the Danish Investigations of Arrhythmias and Mortality on Dofetilide (DIAMOND) study[14]. Unlike amiodarone, it lacks hepatotoxic or pulmonary side effects, making it preferable for long-term use in specific populations[14].
Global Market Dynamics and Growth Drivers
The global dofetilide market was valued at $350 million in 2024 and is projected to grow at a 5.5% CAGR, reaching $550 million by 2033[10]. Key drivers include:
Rising Prevalence of Atrial Fibrillation
Atrial fibrillation affects over 33 million individuals globally, with incidence rates climbing due to aging populations and comorbid conditions like hypertension and diabetes[9]. Dofetilide’s role in reducing stroke risk and hospital readmissions underpins its demand, particularly in North America, which accounted for 45% of market share in 2023[9].
Genericization and Cost Accessibility
Since the expiration of Pfizer’s patents, 14 generic versions of dofetilide have entered the market, catalyzing price competition[13]. The average cost for a 60-capsule supply of 125 mcg dofetilide is $16, with generics priced 15–20% lower than the brand-name Tikosyn[12]. This affordability has expanded access in emerging markets, where cardiovascular disease burdens are rising[10].
Regulatory and Clinical Endorsements
The FDA’s Abbreviated New Drug Application (ANDA) pathway has accelerated generic approvals, while post-marketing surveillance ensures compliance with safety standards[6]. Clinical guidelines from the American Heart Association endorse dofetilide for patients with structural heart disease, reinforcing its therapeutic legitimacy[14].
Competitive Landscape and Market Segmentation
Key Players and Strategic Moves
The market is dominated by generic manufacturers, including Aurobindo Pharma, Teva Pharmaceuticals, and Sun Pharma, which collectively hold 60% of the market share[13]. Exelan Pharmaceuticals, through NDC 76282-0755, competes by leveraging cost-efficient production and partnerships with ambulatory surgical centers[4][9].
Application and Distribution Channels
- Hospitals account for 70% of consumption, driven by inpatient arrhythmia management[9].
- Ambulatory surgical centers represent the fastest-growing segment, projected to grow at 8.4% CAGR due to outpatient cardioversion trends[10].
- Online pharmacies are gaining traction, offering discounts of up to 25% compared to retail pharmacies[10].
Regional Market Insights
North America: Sustained Dominance
North America’s market leadership stems from high diagnosis rates, robust reimbursement policies, and the presence of major pharmaceutical companies. The U.S. alone contributed $157 million in 2024, driven by Medicare Part D coverage for antiarrhythmics[10].
Asia-Pacific: Emerging Growth Hub
Countries like India and China are witnessing 7–9% annual growth due to improving healthcare infrastructure and government initiatives to combat cardiovascular diseases[10]. Local manufacturers are capitalizing on lower production costs to supply generic dofetilide at 30–40% discounts compared to Western markets[10].
Price Projections and Cost Analysis
Current Pricing Trends
As of 2025, dofetilide prices exhibit mid-single-digit annual erosion due to generic competition[10]. For NDC 76282-0755, the average wholesale price (AWP) is $0.27–$2.85 per capsule, depending on dosage strength[12].
Future Price Trajectory
By 2030, prices are expected to stabilize at $0.20–$2.50 per capsule, with total treatment costs for a 30-day supply falling below $50[10]. Factors influencing this trend include:
- Biosimilar entry: Pipeline biosimilars targeting niche arrhythmia subpopulations could further pressure prices.
- Volume-based procurement: Government tenders in emerging markets will drive bulk purchasing discounts[9].
Industry Expert Insight:
“The genericization of dofetilide has democratized access to arrhythmia care, but manufacturers must balance cost reductions with sustainable profitability.”[10]
Regulatory and Production Challenges
FDA Scrutiny and Compliance
Exelan Pharmaceuticals’ NDC 76282-0755 is subject to FDA’s Current Good Manufacturing Practices (CGMP), with recent inspections highlighting advancements in quality control[4]. The drug’s inclusion in the FDA’s National Drug Code Directory ensures traceability, though it does not confer therapeutic equivalence[6].
Supply Chain Risks
Active pharmaceutical ingredient (API) shortages and geopolitical trade disruptions pose risks, potentially increasing production costs by 10–15%[10]. Mitigation strategies include dual-sourcing APIs from India and South Korea[9].
Conclusion
The dofetilide market is poised for steady growth, fueled by arrhythmia prevalence and generic expansion. NDC 76282-0755, as part of Exelan’s portfolio, will benefit from cost-optimized production and strategic distribution. However, price erosion and regulatory hurdles necessitate agile business models to maintain profitability. Stakeholders must prioritize R&D investments in sustained-release formulations and digital health integrations to enhance patient adherence[9][10].
Key Takeaways:
- Dofetilide’s market will grow to $550 million by 2033, driven by atrial fibrillation prevalence and generic access.
- Price erosion at 5.5% CAGR will improve affordability but challenge manufacturer margins.
- North America remains the revenue hub, while Asia-Pacific offers untapped growth potential.
- Regulatory compliance and supply chain resilience are critical for sustaining market presence.
References
- https://www.rootsanalysis.com/reports/next-generation-drug-conjugates-market.html
- https://www.emergenresearch.com/industry-report/pharmacogenomics-market
- https://www.brickeconomy.com/set/76282-1/lego-guardians-of-the-galaxy-rocket-baby-groot
- https://www.findacode.com/ndc/labelers/Exelan_Pharmaceuticals,_Inc.--76282
- https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eec3c37e-83a7-4195-bccf-cd5973459eef
- https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
- https://www.zionmarketresearch.com/report/naloxone-market
- https://www.globenewswire.com/news-release/2025/03/05/3037571/28124/en/7MM-7-9-Bn-Parkinson-s-Disease-Market-Drug-Forecast-and-Market-Analysis-2023-2025-2033-Novel-Symptomatic-treatments-will-continue-to-shape-the-PD-market.html
- https://www.datainsightsmarket.com/reports/dofetilide-1175626
- https://www.verifiedmarketreports.com/product/dofetilide-market/
- https://www.marketresearchintellect.com/product/global-dofetilide-market/
- https://www.drugs.com/price-guide/dofetilide
- https://www.drugpatentwatch.com/p/generic-api/dofetilide
- https://en.wikipedia.org/wiki/Dofetilide
- https://www.drugpatentwatch.com/p/drug-price/ndc/index.php?query=75907-0054
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