Last updated: March 21, 2026
What is the Status of NDC 54092-0100?
NDC 54092-0100 refers to a specific pharmaceutical product listed in the National Drug Code directory. The product, identified as a drug with a particular formulation, packaging, and manufacturer, has established market presence since its approval date. As of 2023, this drug addresses a designated therapeutic area, with safety and efficacy data supporting its use.
Market Overview
Therapeutic Use and Indication
The drug is indicated for [specify indication], targeting conditions such as [list conditions]. It belongs to the [drug class] and offers an alternative or adjunct to existing treatments.
Competitor Landscape
The product faces competition from [list main competitors], which vary in formulation, delivery method, and pricing. The market includes generic and branded options, with generics capturing a significant share due to price competitiveness.
Market Size and Adoption Rates
The US market for the drug's indication is estimated at $[specify amount] in 2023, with projected compound annual growth rates (CAGR) of [x]% through 2028. Adoption rates depend on factors such as clinical guidelines updates, formulary placements, and payer coverage.
Reimbursement and Payer Coverage
Reimbursement policies influence market access. Centers for Medicare & Medicaid Services (CMS) and private insurers predominantly reimburse based on negotiated rates. Coverage for NDC 54092-0100 improves as clinical data supports its outcomes and cost-effectiveness.
Price Trends and Projections
Historical Pricing Data
- Retail list price (2021): $[x] per unit.
- Average selling price (ASP) (2022): $[x], reflecting discounts and rebates.
- Wholesale acquisition cost (WAC): $[x], includes manufacturer pricing before discounts.
Factors Influencing Price Dynamics
- Patent status: Patent expiration in [year] introduces generics.
- Market penetration: Increasing adoption reduces the average price due to competition.
- Regulatory changes: New indications or label updates may influence demand.
- Contractual discounts: rebates negotiated with payers impact net prices.
Price Forecast for 2024–2028
| Year |
Estimated Average Price (Per Unit) |
Notes |
| 2024 |
$[x] |
Stabilization as generic competition intensifies. |
| 2025 |
$[x] |
Slight decrease projected due to increased generics. |
| 2026 |
$[x] |
Price likely to stabilize with mature market. |
| 2027 |
$[x] |
Potential for minor upward adjustment with new indications. |
| 2028 |
$[x] |
Market saturation and patent exclusivity expiration influence pricing. |
Price Comparison with Competitors
| Product |
Price per Unit |
Market Share |
Notes |
| NDC 54092-0100 |
$[x] |
[x]% |
Branded product with established reputation. |
| Competitor A |
$[y] |
[y]% |
Generic version more price competitive. |
| Competitor B |
$[z] |
[z]% |
New entrant with lower price point. |
Key Market Risks
- Patent cliff: Loss of exclusivity causing price erosion.
- Regulatory delays: Post-market safety issues could impact sales.
- Payer resistance: Increasing utilization of generics or biosimilars.
- Market saturation: Higher competition reducing price resilience.
Summary
NDC 54092-0100 operates in a competitive environment with shifting pricing influenced by patent status, market penetration, and competitor pricing. Price projections suggest gradual declines post-patent expiration, consistent with historical generic entry patterns. Market growth remains tied to clinical adoption and reimbursement policies.
Key Takeaways
- The product’s current price is $[x] per unit, with a downward trend forecasted.
- Patent expiration expected in [year], likely leading to increased generic competition.
- Market size for the target indication is $[amount], with steady growth projections.
- Pricing will be affected by insurance coverage, formulary placement, and clinical adoption.
- Competitor pricing ranges from $[min] to $[max], with generics typically priced lower.
FAQs
1. What factors primarily influence the price of NDC 54092-0100?
Market competition, patent status, reimbursement policies, and market penetration influence its price.
2. When does patent expiration occur?
The patent is set to expire in [year], after which generics are expected to enter the market.
3. How does generic entry typically affect pricing?
Generic entry tends to reduce the price by 20–50%, depending on market dynamics.
4. What is the expected impact of new indications on pricing?
New indications could stabilize or slightly increase prices if they expand the market or improve clinical positioning.
5. How will reimbursement changes influence the product's market viability?
More favorable reimbursement improves market access, while restrictive policies reduce demand and pricing power.
References
[1] U.S. Food and Drug Administration. (2023). Approved Drug Products.
[2] IQVIA. (2023). National Prescription Audit.
[3] Medicare.gov. (2023). Coverage policies for pharmaceuticals.
[4] FDA. (2023). Patent and exclusivity data.
[5] EvaluatePharma. (2023). Market forecasts and drug pricing trends.
