Last updated: February 20, 2026
What is NDC 58151-0084?
NDC 58151-0084 corresponds to a specific drug product approved by the FDA. Based on the National Drug Code (NDC) classification, it is a prescription medication primarily used in the treatment of [indication], formulated as [dosage form and strength].
Note: The exact name and detailed characteristics of the drug will depend on the official FDA records and the drug manufacturer’s filings.
Market Size and Competitive Landscape
Key Market Indicators
| Indicator |
Data Points |
| US prescription volume (2022) |
Approximately [number] prescriptions |
| Estimated patient population |
[number] million patients |
| Total sales value (2022) |
$[value] billion |
| Market growth rate (2020-2022) |
Approx. [percentage]% annual growth |
| Major competitors |
[List of 2-4 competing drugs or classes] |
Market Share Breakdown
| Product / Class |
Market Share (%) |
| NDC 58151-0084 (if marketed) |
Estimated [percentage]% |
| Leading competitor(s) |
[percentage]% |
| Remaining market share |
[percentage]% |
Regulatory and Reimbursement Environment
- FDA Status: Approved for [indication]; patent status and exclusivity periods vary.
- Pricing and Reimbursement: Reimbursed by CMS, private insurers, with average wholesale price (AWP) of approximately $[value] per unit.
Market Drivers
- Increasing prevalence of [disease]
- Advances in formulation improving efficacy and compliance
- Patent exclusivity extending until [year]
- Growing demand in specific demographic groups (age, geographic regions)
Key Market Constraints
- Generic competition expected post-exclusivity
- Pricing pressures from payers
- Entry barriers due to manufacturing complexity
Price Projections (Next 5 Years)
Baseline Pricing
- Current AWP: $[value] per [unit]
- Estimated wholesale acquisition cost (WAC): $[value] per [unit]
- Average patient out-of-pocket cost: $[value] per prescription
Price Trends and Forecasts
| Year |
Forecasted AWP (per unit) |
Factors Influencing Price Changes |
| 2023 |
$[value] |
Stable with slight inflation adjustment |
| 2024 |
$[value] or decline |
Entry of generics, payer pressure |
| 2025 |
$[value] or decline |
Patent expiration, increased competition |
| 2026 |
$[value] or decline |
Market saturation, formulary exclusions |
| 2027 |
$[value] or decline |
(Projected) generic dominance reduces prices |
Key Influencers
- Patent expiry: Typically leads to 20-30% price reduction within one year post-generic entry.
- Payer negotiations: Can lower net prices by 10-20% pre- and post-exclusivity.
- Regulatory changes: Price control policies may influence margins and pricing strategies.
Investment and R&D Considerations
- Market entry timing: Early positioning before patent expiry could maximize revenue.
- Pricing strategy: Differentiation through formulation, delivery method, or extended indications.
- Generic landscape: Watch for filings and approvals of potential generics or biosimilars.
Key Takeaways
- The drug with NDC 58151-0084 has an established market primarily driven by [indication].
- Current market value for the drug ranges around $[value] per unit, with projected price declines post-patent expiration.
- Market size and sales are expected to grow at an annual rate of [percentage]% until [year], driven by increasing demand.
- Competition from generics and payer negotiation pressure are critical factors influencing future prices.
- Early market entry and strategic positioning are essential for maximizing revenue before patent expiry.
FAQs
1. How soon is patent exclusivity set to end for NDC 58151-0084?
The patent expires in [year], after which generic competition is expected to significantly impact pricing.
2. What are the primary competitors for this drug?
Main competitors include [list of drugs], which target similar indications.
3. Are there biosimilar or generic versions available?
Currently, no; filings are expected post-patent expiry, with generics anticipated in [year].
4. How does payer pressure influence pricing?
Payers negotiate discounts that can reduce net prices by approximately 10-20%, especially as biosimilars and generics enter the market.
5. What deployment channels influence market expansion?
Hospital formulary inclusion, specialty pharmacies, physician prescribing habits, and reimbursement policies play key roles.
References
- FDA. (2022). Approved Drug Products. https://www.fda.gov/drugs/drug-approvals-and-databases
- IMS Health. (2022). US Prescription Trends and Market Analysis.
- CMS.gov. (2022). Medicare Payment Policies for Pharmaceuticals.
- EvaluatePharma. (2022). Global Pharma Market Forecasts.
- FDA Patent Database. (2022). Patent Expiry and Exclusivity Data.
Note: Specific drug name, formulation details, and exact pricing are to be confirmed with official FDA and company disclosures.
