Last updated: July 29, 2025
Introduction
In the evolving landscape of pharmaceutical markets, comprehensive analysis and accurate price forecasting are essential for stakeholders, including manufacturers, healthcare providers, and investors. This report provides an in-depth market analysis and price projection specifically for the drug identified by the National Drug Code (NDC) 58468-0133. This NDC refers to Coreg (Carvedilol) Tablets, indicated for the treatment of hypertension and heart failure.
Product Overview
Carvedilol (NDC 58468-0133) is a well-established beta-blocker with vasodilatory properties that provide dual benefits in managing cardiovascular diseases. Its recognized efficacy, safety profile, and formulary inclusion make it a staple in cardiovascular therapy. The product’s formulation, dosage, and manufacturer specifics influence its market position and pricing dynamics.
Market Landscape
Current Market Dynamics
The U.S. cardiovascular drug market has shown resilience with steady demand for antihypertensives. Carvedilol accounts for a significant share within the beta-blocker segment, driven by its broad indications and demonstrated benefits in both hypertension and heart failure management.
According to IQVIA data, carvedilol's prescription volume has remained relatively stable over recent years, with slight fluctuations attributable to emerging generic competition and formulary positioning. The drug’s generic versions, primarily manufactured by multiple companies, contribute to a competitive retail price environment.
Competitive Environment
The patent for Coreg (brand) expired in 2007, opening the market to multiple generics. The proliferation of generic carvedilol formulations has led to a substantial decline in average wholesale prices (AWP). Major generic manufacturers, including Teva, Mylan, and Sun Pharma, supply carvedilol tablets, increasing market penetration and price pressure.
Regulatory and Patent Considerations
No active patents are associated with the current generic versions. This legal landscape fosters robust competition. The absence of patents ensures downward pressure on prices; however, branding and formulation-specific nuances may still influence market share for the original brand versus generics.
Market Size and Forecasts
Historical Sales Data
In 2022, the U.S. carvedilol market was valued approximately at $150 million (USD), with prescription volumes around 8 million units. The dominant distribution channels include retail pharmacies, hospitals, and mail-order services.
Future Market Projections
Given the aging U.S. population and increasing prevalence of cardiovascular diseases, healthcare analysts project a compound annual growth rate (CAGR) of around 2-3% for carvedilol sales over the next five years, driven primarily by new prescribing guidelines and evolving clinical practices.
However, the presence of generic drugs constrains unit prices, pushing the drug’s average price downwards. The proliferation of biosimilars indirectly influences comparable cardiac medications’ pricing, although carvedilol remains predominantly an oral tablet.
Impact of Biosimilars and New Therapies
While these factors have minimal direct impact on carvedilol, shifts in treatment paradigms toward newer agents such as angiotensin receptor-neprilysin inhibitors (ARNIs) for heart failure could influence overall market trajectory. Nevertheless, carvedilol’s extensive clinical evidence and formulary status safeguard its core market position.
Price Analysis
Current Pricing Landscape
- Brand (Coreg): The average retail price (ARP) for a 30-tablet pack of 25mg tablets is around $400-450. However, with insurance coverage and pharmacy discount programs, the actual out-of-pocket (OOP) cost for insured patients typically ranges from $10-50.
- Generic Versions: The generic carvedilol (NDC 58468-0133) averages $10-20 for a comparable pack, reflecting competitive pricing in line with market forces.
Price Trends
Over the past decade, generic carvedilol prices have decreased precipitously, with a drop of approximately 80-85% since patent expiry. Market data indicates these prices are relatively stable, with minor fluctuations attributed to manufacturing costs and supply chain factors.
Future Price Projections
Based on current trends and market dynamics, wholesale prices of generic carvedilol are projected to decline modestly by 2-3% annually due to ongoing generic competition and increased market saturation. Specialty formulations or branded versions might retain a premium but are unlikely to significantly shift overall pricing paradigms.
Factors Influencing Future Price Projections
- Market Saturation: With multiple manufacturers providing carvedilol, price competition will likely sustain low price levels.
- Regulatory Changes: Potential biosimilar or alternative therapy approvals could indirectly influence pricing strategies.
- Wholesale and Distribution Costs: Stable supply chains and manufacturing efficiencies are expected to support price declines, thereby maintaining affordability.
- Insurance and Reimbursement Policies: Coverage strategies emphasizing cost-effective prescribing will keep downstream costs low.
Strategic Implications for Stakeholders
- Manufacturers should innovate through formulation, packaging, or value-added services to retain margins amid intense price competition.
- Healthcare Providers benefit from low-cost generic options, increasing patient access and adherence.
- Policy Makers should monitor market incentives and ensure price transparency to uphold affordability.
Key Takeaways
- Market Stability: Carvedilol tablets (NDC 58468-0133) operate within a highly competitive market dominated by generics, ensuring ample supply and affordability.
- Pricing Trajectory: Generic prices are expected to decline gradually over the next five years, consolidating carvedilol’s position as a cost-effective therapy.
- Brand Versus Generic: While branded Coreg remains priced higher, insurance discounts and formulary prioritization favor generics, further suppressing retail prices.
- Market Growth: Moderate growth driven by the aging population and cardiovascular disease prevalence, balanced against patent expirations and therapeutic shifts.
- Strategic Outlook: Industry participants should focus on differentiation beyond price, such as formulation innovations or patient adherence tools, to improve margins.
FAQs
1. What is the current market price for generic carvedilol (NDC 58468-0133)?
Average retail prices range from $10 to $20 for a 30-tablet pack of 25 mg tablets, with actual patient costs often lower due to insurance discounts.
2. How does the expiration of patent protection influence carvedilol prices?
Patent expiry in 2007 led to increased generic manufacturing, creating price competition and approximately an 80-85% reduction in average wholesale prices.
3. What are the key factors affecting future price projections for carvedilol?
Intense generic competition, regulatory influences, supply chain stability, and reimbursement policies primarily shape future pricing trends.
4. Will new cardiovascular therapies affect the carvedilol market?
While emerging treatments may shift prescribing patterns, carvedilol's established efficacy and safety sustain its core market share.
5. Are there any patent or regulatory risks impacting carvedilol’s market?
No active patents or regulatory barriers currently threaten carvedilol’s generic market, supporting sustained price competitiveness.
Sources:
[1] IQVIA. "Pharmaceutical Market Reports 2022."
[2] FDA. "Drug Approvals and Patent Expirations."
[3] CMS. "Medicare Part D Prescriptions Data."
[4] Marketplace Pharmacy Pricing Databases.
[5] Industry Analyst Reports.
