Last updated: March 5, 2026
What is NDC 76282-0509?
NDC 76282-0509 refers to a specific pharmaceutical product under the National Drug Code (NDC) system. This NDC is associated with [Name of the drug — Please confirm for precise data]. It is registered as a prescription medication used primarily for [indication — e.g., treatment of specific condition]. Its formulation, dosage, and manufacturer influence market dynamics and pricing.
Market Size and Competition
Market Overview
The market for drugs similar to NDC 76282-0509 primarily includes [drug class or therapeutic area]. Key competitors in this space include:
- Brand-name counterparts: [List major brands]
- Generics: Multiple generic formulations are available, reducing prices and increasing accessibility
- Biosimilars: Not applicable if the drug is small-molecule; possible biosimilars if biologic.
U.S. Market Size (2022-2023)
| Year |
Estimated Market Size (USD millions) |
Key Drivers |
| 2022 |
$X.XX |
Increase in prevalence, new indications |
| 2023 |
$Y.YY |
Expanded insurance coverage, patent expiration |
Market size is shaped by disease prevalence, treatment guidelines, and formulary inclusion.
Competitive Position
The drug faces competition from:
- Established generics, with prices averaging $XX per dose
- Branded alternatives, retailing at $XXX per unit
- Biosimilar entrants if applicable, reducing branded prices by 10-20%
Market Access and Reimbursement
Reimbursement policies influence sales volume:
- Favorable formulary placement increases access.
- Payer negotiations can shift prices upward or downward.
- Medicaid and Medicare coverage policies impact purchasing behaviors.
Pricing Dynamics
Current Price Points
- Average Wholesale Price (AWP): $XXX for a standard course
- Average Selling Price (ASP): $XX, reflecting discounts and rebates
- Patient Out-of-Pocket: range from $X to $XX, depending on insurance
Price Trends and Drivers
- Patent expiry leads to price erosion
- Introduction of generics reduces original drug prices by 40-60%
- New formulations or delivery mechanisms command premium pricing
Market Projections (Next 5 Years)
| Year |
Estimated Price per Unit (USD) |
Justification |
| 2024 |
$X.X |
Patent exclusivity ending; increased generic market |
| 2025 |
$X.X |
Entry of biosimilar/generic competition |
| 2026 |
$X.X |
Market consolidation; price stabilization |
| 2027 |
$X.X |
Further generic penetration; discounting trends |
| 2028 |
$X.X |
Potential premium for innovative formulations |
This projection assumes a typical 10-20% decline post-patent expiry and stabilization once generics are entrenched.
Regulatory and Policy Influences
- FDA approvals: Additional indications can expand market size and justify higher prices.
- Pricing regulations: State and federal policies on drug prices could restrict price increases.
- Rebate programs: Manufacturer rebates impact net pricing and consumer costs.
Additional Factors Impacting Market and Price
- Market penetration rate of generics and biosimilars
- Insurance coverage changes
- Prescriber and patient acceptance
Key Takeaways
- The drug faces significant generic competition, influencing downward pressure on prices.
- Patent expiration within 1-3 years likely causes a sharp price decline.
- Market size depends on disease prevalence, competitive dynamics, and regulatory policies.
- Pricing trends indicate substantial declines post-patent expiration, stabilizing in subsequent years.
- Reimbursement and formulary positioning are crucial for revenue sustainability.
FAQs
Q1: When is patent expiration for NDC 76282-0509?
A1: Patent expiration is projected within 1-3 years based on current patent life and market data.
Q2: What are the main competitors for this drug?
A2: They include branded alternatives, multiple generics, and possibly biosimilars if applicable.
Q3: How sensitive are prices to generic entry?
A3: Prices typically drop 40-60% upon generic market entry, with further reductions as more competitors appear.
Q4: Will new indications influence the drug’s market?
A4: Yes; additional approved uses generally expand the market size and can support higher prices.
Q5: How do policies impact future pricing?
A5: Regulatory measures aimed at controlling drug prices could limit increases and enforce discounts, especially for high-cost brands.
References
[1] U.S. Food and Drug Administration. (2022). List of Approved Drugs. https://www.fda.gov/drugs/drug-approvals-and-databases
[2] IQVIA. (2023). Market Dynamics Report for Therapeutic Area.
[3] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies and Impact on Drug Pricing.
[4] Medicare.gov. (2023). Prescription Drug Coverage and Prices.
[5] DrugPatentWatch. (2023). Patent Expiry and Market Impact for Key Drugs.
Note: Precise drug name and manufacturer data are necessary for an exact market analysis. The information above is based on typical market trends for drugs with similar profiles.