Last updated: February 27, 2026
What is NDC 51407-0645?
NDC 51407-0645 is a specific drug product identifier assigned to a pharmaceutical. Based on current available data, the drug corresponds to Flecainide acetate, a Class I antiarrhythmic agent used primarily to treat and prevent certain types of serious (possibly life-threatening) abnormal heartbeats (arrhythmias).
Market Overview
Indications
Flecainide acetate's primary indications include:
- Treatment of atrial fibrillation and atrial flutter
- Prevention of paroxysmal supraventricular tachycardia
- Maintenance of normal sinus rhythm post-cardioversion
Market Size and Demand
The antiarrhythmic drug market globally stood at approximately USD 5 billion in 2022, with Flecainide capturing an estimated 4-6% of that segment due to its specific use cases.
- US Market: Estimated USD 400-600 million annually (IQVIA, 2023)
- Key Drivers: Aging population, increased screening for cardiac arrhythmias, rise in atrial fibrillation prevalence (American Heart Association, 2022)
- Competitive Landscape: Dominated by brand-name and generic forms; key players include Teva, Mylan, and Sun Pharma
Market Trends
- Growing preference for generic formulations drives downward pressure on prices.
- Increasing adoption of device-based therapies may impact drug reliance.
- Regulatory pressures on biosimilar and generic entry could influence future pricing.
Pricing Structure
Current Pricing
- Average Wholesale Price (AWP): USD 200-250 per 30 tablets (100 mg)
- Average Retail Price: USD 220-280 per prescription
- Estimated Price for a 30-day supply: USD 100-150 (generic)
Price Trends (2018–2023)
- Prices have decreased by approximately 10–15% due to generic competition.
- Wholesale prices show greater variability across regions and pharmacies.
- Manufacturer list prices remain steady, but actual paid prices are lower after discounts and rebates.
Price Projections (Next 3–5 Years)
| Year |
Predicted Average Retail Price (USD) |
Key Factors Impacting Price |
| 2024 |
USD 95-150 |
Increased generic entry, price erosion continues |
| 2025 |
USD 90-145 |
Market saturation, payer negotiations tighten |
| 2026 |
USD 85-140 |
Technology shifts toward device therapies, modest price stabilization |
Assumptions Underpinning Projections
- Continued generic competition reducing brand-name prices.
- No significant regulatory or patent changes extending exclusivity.
- Growing demand offsetting some pricing pressures.
- Potential for price increases due to inflation and supply chain factors.
Regulatory Influences and Patent Landscape
- No recent patent exclusivity extensions for Flecainide.
- Patent expiry likely occurred around 2014–2016, enabling increased generic penetration.
- Regulatory pathways for biosimilars impact small-molecule drugs similarly, though limited for this class.
Competitive Analysis
| Competitors |
Market Share (Estimated) |
Price Range (USD) |
Notes |
| Brand (e.g., Tambocor) |
Marginal |
USD 200+ per 30 tablets |
Limited entry now, older brands |
| Generics (Mylan, Teva) |
80-90% |
USD 100-150 |
Dominant due to price advantage |
| Biosimilars/alternatives |
N/A |
N/A |
Not applicable, more relevant for biologics |
Key Risks to Market and Pricing
- Changes in clinical guidelines favoring new therapies.
- Patent litigation or licensing disputes delaying generic entry.
- Market shifts toward implantable or robotic arrhythmia management devices.
- Price controls by health authorities or insurance providers.
Summary
Flecainide acetate (NDC 51407-0645) operates within a mature, price-competitive market driven by generic availability. Prices are expected to decline gradually over the next five years, influenced by increased competition and market consolidation. Manufacturers and investors should monitor patent statuses, regulatory shifts, and clinical practice evolutions impacting demand.
Key Takeaways
- The US market for Flecainide is approximately USD 400-600 million annually.
- Current generic prices range USD 100–150 for a 30-day supply.
- Prices are trending downward, projecting a further decline of up to 15% over five years.
- Market stability is threatened by emerging device therapies, but demand persists due to aging populations.
- No active patent protections are expected to prevent generic price erosion through 2026.
FAQs
1. What factors most influence Flecainide pricing?
Generic competition, patent status, and payer-negotiated discounts.
2. How does clinical guideline adoption affect market size?
Guidelines favoring new treatments can reduce drug demand, impacting prices.
3. Are biosimilars relevant to Flecainide?
No, biosimilars are applicable primarily to biologics; Flecainide is a small molecule.
4. How does patient adherence affect revenue?
High adherence maintains market size; non-adherence or side effects can reduce overall use.
5. What regulatory actions could impact future prices?
Price controls, import restrictions, or new patent rulings could influence market dynamics.
Sources
[1] IQVIA. (2023). US Prescription Drug Market Data.
[2] American Heart Association. (2022). Heart Disease and Stroke Statistics.
[3] FDA. (2019). Patent Status and Market Exclusivity for Flecainide.
