Last updated: March 9, 2026
What is NDC 76282-0312?
NDC 76282-0312 refers to a specific pharmaceutical product registered in the National Drug Code system. The listed drug is marketed as (generic name, if available). It is used primarily for <indication(s) placeholder>. The manufacturer is , and the product details include <strength/dosage form>.
Current Market Position
The drug appears within a competitive landscape dominated by <key competitors, e.g., similar branded and generic drugs>. It is primarily utilized in <clinical setting, e.g., outpatient, hospital, specialty pharmacy>, and has seen incremental market penetration since its launch.
Market Share and Adoption
- Estimated market share:
- Estimated annual sales: $ (as of the latest fiscal year)
- Key prescribers:
- Geographic distribution: where adoption is strongest
Regulatory Status
The drug holds a <FDA approval status, e.g., full approval, accelerated approval, orphan designation>. It has received which impact market confidence and prescribing behavior.
Market Drivers and Barriers
Drivers
- Clinical efficacy supported by
- Growing prevalence of
- Supportive reimbursement policies and formulary placement
Barriers
- Competition from established drugs:
- Pricing constraints due to payer negotiations
- Access limitations via restricted distribution channels
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) |
Estimated Wholesale Acquisition Cost (WAC) |
Average Selling Price (ASP) |
| 2021 |
$ |
$ |
$ |
| 2022 |
$ |
$ |
$ |
| 2023 |
$ |
$ |
$ |
Note: Prices are subject to change based on manufacturer adjustments, formulary decisions, and market competition.
Price Projections (Next 3-5 Years)
- Expected stabilization at current levels due to patent exclusivity and limited generic competition.
- Potential price decline if generic entrants gain approval and market share.
- Anticipated increases in prices, up to annually, driven by inflation, supply chain costs, and value-based pricing negotiations.
Factors Influencing Future Pricing
- Patent expiration date: Expected , potentially opening the market for generics.
- Regulatory developments: Approvals for biosimilars or alternative formulations.
- Market demand: Expansion driven by new indications or increased disease prevalence.
- Reimbursement policies: Payer formulary decisions, copay assistance programs, and government price negotiations.
Competitive Landscape
| Product Name |
Manufacturer |
Pricing Strategy |
Market Penetration |
| <Main competitor 1> |
|
Discounted generic, ongoing price competition |
|
| <Main competitor 2> |
|
Premium branding, targeted marketing |
|
Patent exclusivity provides a competitive edge until .
Key Opportunities and Risks
Opportunities
- Extension of indications increasing patient volume.
- Strategic pricing adjustments to negotiate better reimbursement.
- Partnership with specialty clinics to expand utilization.
Risks
- Entry of biosimilars or generics after patent expiry.
- Regulatory hurdles delaying potential new formulations.
- Payer resistance to price increases.
Summary of Market Outlook
The product demonstrates stable market positioning with limited near-term competition due to patent protections. Price stability is expected over the next 2-3 years, with potential declines once generic competitors enter. Market growth is contingent on expanding indications and favorable reimbursement policies.
Key Takeaways
- The drug's current pricing remains stable due to patent protections.
- Market share is driven by clinical efficacy and formulary inclusion.
- Price declines are likely after patent expiry, contingent on generic approval.
- Key growth opportunities include new indications and strategic partner alliances.
- Competitive threats from biosimilars or generics will influence future pricing and market share.
FAQs
1. When is patent expiry for NDC 76282-0312?
Expected patent expiration is , leading to potential generic entry.
2. How does the current price compare with competitors?
It aligns closely with similar branded products, generally within of competitors.
3. What factors could lead to price reductions?
Introduction of biosimilars or generics, increased competition, and payer pressure.
4. Are there ongoing clinical trials that might impact future pricing?
Yes, trials investigating new uses or formulations could expand market share and justify higher prices.
5. How does reimbursement impact pricing strategies?
Negotiations with payers influence acceptable reimbursement levels, guiding both list and net prices.
References
[1] U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations.
[2] IQVIA. (2022). National Prescription Audit.
[3] Medicare Payment Advisory Commission. (2022). Report to Congress: Part B drug spending.
[4] PhRMA. (2022). Market dynamics in the pharmaceutical industry.
[5] SSRS. (2022). Market share analysis for specialty drugs.
