Last updated: February 13, 2026
Overview of the Product
NDC 69452-0160 is a nitroglycerin sublingual tablet. Used primarily for acute relief of angina pectoris due to coronary artery disease, this medication has a long-standing indication. Its formulation typically comes in 0.3 mg, 0.4 mg, or 0.6 mg doses, packaged in blister packs.
Market Landscape
The global angina market valued at approximately $12 billion in 2022 is dominated by nitroglycerin and other nitrates. The key segments include:
- Generic nitroglycerin products
- Brand-name alternatives (e.g., Nitrostat by Pfizer)
- Over-the-counter (OTC) and prescription formulations
Current Manufacturing and Supply Dynamics
- Multiple manufacturers produce nitroglycerin tablets, leading to high competitive pressure.
- The drug remains off-patent for decades, thus mainly available as generics.
- Production costs are driven by sourcing of active pharmaceutical ingredients (API) and compliance with regulatory standards.
Market Position of NDC 69452-0160
- Identifies a specific generic manufacturer, likely a low-cost producer.
- Shares market predominantly held by established generic pharmaceuticals.
- Limited differentiation based on formulation; price and availability are main competitive factors.
Pricing Data
- Average wholesale acquisition cost (WAC) for nitroglycerin sublingual tablets is approximately $0.10 to $0.20 per tablet.
- For branded products like Nitroglycerin Tablets, prices range between $1.00 and $2.00 per tablet.
- Generic prices are approximately 80-85% lower than brand names.
| Drug Formulation |
Approximate Price per Tablet |
Notes |
| NDC 69452-0160 (generic) |
$0.10 - $0.20 |
Estimated wholesale price |
| Branded Nitroglycerin (Nitrostat) |
$1.00 - $2.00 |
Brand-name market leader |
Market Penetration and Growth Trends
- Usage remains steady due to the longstanding indication.
- Switch to sublingual administration remains preferred for rapid relief.
- Pricing pressure from generics is intensifying with increased competition, leading to further decreases in cost.
Regulatory and Reimbursement Environment
- Approved by FDA with extensive history.
- Reimbursement typically covers both prescription and OTC formulations via Medicaid, Medicare, and private insurance.
- Slight upward pressure on prices in certain markets due to regulatory requirements for quality and packaging standards.
Future Price Projections
- Short-term (1-2 years): Prices are expected to stabilize around current levels. Factors influencing prices include supply chain stability and regulatory compliance costs.
- Medium-term (3-5 years): Slight decline anticipated driven by increased generic competition, with prices potentially decreasing by 10-20% annually.
- Long-term (5+ years): Price erosion may plateau as demand stabilizes and patent protections are non-existent.
Factors Affecting Price Trends
- Market Competition: Entry of new generic manufacturers will exert downward pressure.
- Raw Material Costs: Fluctuations in API prices could temporarily influence retail costs.
- Regulatory Changes: Stricter manufacturing standards may increase compliance costs, offsetting some price declines.
- Reimbursement Policies: Drugs with broader coverage could maintain pricing stability.
Key Takeaways
- NDC 69452-0160 is a generic nitroglycerin sublingual tablet with a stable market presence.
- Price points hover around $0.10-$0.20 per tablet, with little variation among competitors.
- Market growth remains flat with steady demand for angina relief.
- Price reductions of 10-20% annually are likely over the next five years due to intense generic competition.
- Regulatory and supply chain factors could cause short-term price fluctuations.
FAQs
1. How does the price of NDC 69452-0160 compare with branded alternatives?
The generic version is approximately 80-85% cheaper, with prices around $0.10-$0.20 per tablet versus $1.00-$2.00 for brand-name products.
2. What factors could influence future prices of this drug?
Increased competition, raw material costs, regulatory changes, and reimbursement policies significantly affect pricing.
3. Is there potential for formulation innovation to impact prices?
Limited, since the drug’s formulation has remained largely unchanged for decades. Price reduction is primarily driven by competition rather than innovation.
4. How significant is the market for OTC versions of nitroglycerin?
OTC availability is limited; most formulations remain prescription-only. OTC can influence retail prices but has little impact on wholesale or institutional pricing.
5. What regulatory issues could affect supply or pricing?
Manufacturing compliance with quality standards, supply chain disruptions, or FDA inspections could temporarily affect supply and prices.
References
- IQVIA. "Global Cardiovascular Drugs Market Report," 2022.
- FDA. "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.
- GoodRx. "Nitroglycerin prices and availability," 2023.
- Statista. "Market value of angina medications," 2022.
- Reuters. "Generic drug price trends," 2023.
