Last updated: February 20, 2026
What is NDC 24478-0321?
NDC 24478-0321 is a generic formulation of a cardiovascular drug used to treat hypertension. It is produced by a contract manufacturer and marketed by multiple generic drug companies. Its active ingredient is amlodipine besylate, a calcium channel blocker.
Market Position and Competition
The global hypertension market reached approximately $31 billion in 2022, with generic drugs accounting for 65% of sales. Amlodipine ranks among the top three antihypertensive active ingredients worldwide, with sales exceeding $4 billion annually. Key competitors include:
- Pfizer’s Norvasc (brand)
- Generic amlodipine products from Mylan, Teva, Sandoz, and others
Generic versions, including NDC 24478-0321, capture a significant share of prescriptions due to lower price points. The drug's patent exclusivity expired in 2010, prompting widespread generic entry.
Current Market Dynamics
Pricing Landscape
The average wholesale acquisition cost (WAC) for generic amlodipine ranges from $0.10 to $0.30 per tablet, depending on dosage and packaging. For the 5 mg tablet, typical retail prices:
| Manufacturer |
Price per Tablet |
Pack Size |
Notes |
| Mylan |
$0.12 |
30 tablets |
Common wholesale price |
| Teva |
$0.14 |
30 tablets |
Slight variation |
| Sandoz |
$0.11 |
30 tablets |
Competitive pricing |
The list price for a 30-day supply (30 tablets) typically falls in the $3.00–$9.00 range. Reimbursement through insurance often leads to lower patient out-of-pocket costs, approximately $5 for a 30-day supply.
Demand Trends
Prescription volumes have stabilized at approximately 15–20 million units annually in the US, driven by the drug’s efficacy, safety profile, and inclusion in hypertension treatment guidelines. Market growth is marginal, mostly influenced by demographic shifts and increased awareness of cardiovascular health.
Regulatory Status
No recent regulatory changes have impacted NDC 24478-0321. The drug remains on the FDA’s approved drug list with no current patent challenges for the specific formulation.
Price Projections Analysis (Next 3-5 Years)
Factors Influencing Price Trajectory
- Market saturation: High penetration lowers average prices.
- Manufacturing costs: Slight reduction expected with generic competition.
- Regulatory shifts: No significant upcoming patent litigations or exclusivity periods.
- Pricing regulations: Potential price caps or formulary preferences could pressure prices.
Projection Range
| Year |
Estimated WAC per Tablet |
Estimated Retail Price per 30-Day Supply |
Notes |
| 2023 |
$0.10–$0.15 |
$3–$4.50 |
Current stable prices |
| 2024 |
$0.09–$0.14 |
$2.70–$4.20 |
Slight downward trend due to competition |
| 2025 |
$0.08–$0.13 |
$2.40–$3.90 |
Continued price pressure |
| 2026 |
$0.07–$0.12 |
$2.10–$3.60 |
Market stabilization, slight decline |
Scenario Analysis
- Best case: Increased generic competition could drive prices down to $0.07–$0.09 per tablet, reducing retail prices to approximately $2.10–$2.70.
- Worst case: Supply chain disruptions or regulatory hurdles might sustain prices at current or slightly higher levels, around $0.12–$0.15 per tablet.
Revenue and Market Share Outlook
Assuming annual consumption of 20 million units in the US, the gross sales at current prices approximate:
| Price per Tablet |
Annual Revenue |
Market Share |
| $0.10 |
$2 million |
~13% |
| $0.15 |
$3 million |
~20% |
Presence in large insurance formularies and generic distribution channels minimizes potential revenue growth. The primary revenue driver remains steady prescription volume rather than price increases.
Implications for Stakeholders
- Manufacturers: Focus on cost efficiencies to sustain profitability in a price-pressured environment.
- Investors: Expect modest revenue streams from stable volume with declining price trends.
- Healthcare providers: Favor cost-effective generics, reinforcing demand stability.
Key Takeaways
- NDC 24478-0321 is a generic amlodipine with broad market penetration in the US.
- Prices are expected to decline gradually over the next five years, driven by competition.
- Current retail prices hover around $0.10–$0.15 per tablet.
- Market share remains steady, with revenues primarily supported by prescription volume.
- Regulatory and patent factors are unlikely to impact pricing significantly in the near term.
FAQs
Q1: How does the price of NDC 24478-0321 compare to branded amlodipine?
Branded amlodipine (Norvasc) typically costs $10–$15 per tablet, whereas generic versions like NDC 24478-0321 cost under $0.15, representing a significant cost reduction for payers.
Q2: What are the main competitors to this generic?
Competitors include other generics from Mylan, Teva, and Sandoz, which are similar in price and formulation, with no major differentiators.
Q3: Is there potential for price increases due to shortages?
Supply chain issues could temporarily increase prices; however, the mature market and multiple suppliers mitigate sustained shortages.
Q4: How does formulary inclusion affect pricing?
Formulary status often prioritizes lowest-cost generics, maintaining low prices and limiting premium pricing opportunities.
Q5: What pharmaceutical trends could influence this segment?
Emergence of combination drugs, new hypertensive classes, or regulatory cost controls could shift demand and pricing dynamics.
References
- IQVIA. (2022). Prescription Drug Market Analysis.
- FDA. (2023). Approved Drug List.
- World Health Organization. (2022). Global Cardiovascular Disease Statistics.
- Generics Bulletin. (2022). Market Trends in Generic Cardiovascular Drugs.
