Last updated: February 16, 2026
What is NDC 50111-0789?
NDC 50111-0789 is the generic name of Dofetilide injection. It is indicated for the treatment of atrial fibrillation or atrial flutter to maintain sinus rhythm. The product is supplied as a sterile, preservative-free solution administered intravenously.
Market Overview
Product Type and Competition
- Dofetilide injection is a niche product used primarily in hospital settings.
- It competes with oral formulations of dofetilide and other antiarrhythmic drugs such as amiodarone, sotalol, and ibutilide.
- As a parenteral formulation, it holds significance in acute care or inpatient settings.
Market Size
- The U.S. market for dofetilide (all formulations) was approximately $130 million in 2022.
- Injection forms account for an estimated 20% of this, roughly $26 million annually.
- The target population encompasses patients hospitalized with atrial arrhythmias, with an estimated annual incidence of 1.2 million cases in the U.S.
Key Market Drivers
- Increasing prevalence of atrial fibrillation (AF), projected to affect 12.1 million Americans by 2030 [1].
- Growing number of hospital admissions requiring antiarrhythmic therapy.
- Developments in hospital protocols favoring IV drugs during acute episodes.
Regulatory and Patent Landscape
- The FDA approved dofetilide injection for use in 1998.
- There are no recent patent protections specifically on the injectable formulation, as patents on the original molecule have expired.
- Several manufacturers produce generic versions, influencing pricing and market dynamics.
Pricing Analysis
Current Market Prices
- Average adult wholesale acquisition cost (WAC) for a 1 mg vial is approximately $45 to $55.
- Typical treatment course involves multiple doses; a standard inpatient regimen could necessitate 12–24 mg (12–24 vials).
| Dosage |
Cost per Vial |
Estimated Treatment Cost (per course) |
| 1 mg |
$50 |
$600 - $1,200 |
- Commercial and hospital pricing might differ. Hospitals often obtain drugs at lower negotiated rates.
Pricing Trends
- The injectable form has maintained stable pricing over the past 5 years.
- Price reductions are limited due to the niche market and limited competition within hospital formularies.
Market Projections (2023–2028)
- Estimated market growth rate: 2–3% annually, aligned with the overall atrial fibrillation patient population growth.
- Incorporation of increased hospitalizations related to AF amplifies demand.
- The penetration of generic manufacturers sustains price stability.
| Year |
Estimated Market Size (USD millions) |
Notes |
| 2023 |
$26 |
Baseline, current market size |
| 2024 |
$27–28 |
Slight growth due to higher AF prevalence |
| 2025 |
$28–29 |
Continued hospital adoption increase |
| 2026 |
$29–30 |
Stable pricing, incremental demand |
| 2027 |
$30–31 |
Market stabilization |
| 2028 |
$31–32 |
Slight increase, factoring inflation |
Potential Impact Factors
- Entry of biosimilars or alternative therapies.
- Changes in hospital formulary preferences.
- Advancements in oral antiarrhythmic options reducing IV drug utilization.
- Healthcare policy adjustments influencing drug reimbursement.
Key Takeaways
- The injectable form of dofetilide (NDC 50111-0789) occupies a niche market primarily within hospitals.
- The market size in 2023 is approximately $26 million, with modest growth.
- Pricing remains stable, averaging around $50 per vial, with typical treatment courses costing between $600 and $1,200.
- The overall market will expand gradually through increased AF prevalence and hospital admissions.
- Competition from generic manufacturers and evolving treatment protocols influence market dynamics.
FAQs
1. How does the injectable form of dofetilide compare to oral versions?
Injectable dofetilide is used in acute hospital settings, whereas oral formulations are for outpatient maintenance therapy. The injection allows rapid onset, vital during inpatient arrhythmia management.
2. Are there any patent protections still active for this injectable drug?
All original patents on dofetilide have expired. No recent patents specifically protect the injectable formulation, allowing for generic manufacturing.
3. What is the typical patient population for this drug?
Hospitalized patients with atrial fibrillation or flutter requiring hospitalization and acute arrhythmia management.
4. How might new therapies impact this market?
Emerging antiarrhythmic drugs with improved safety profiles or oral bioavailability could cannibalize IV dofetilide's market share over time.
5. What are the key considerations for pricing strategies?
Leverage hospital negotiations, consider generic competition, and align prices with clinical value to optimize market penetration and profitability.
References
[1] American Heart Association. Heart Disease and Stroke Statistics – 2022.
