Last updated: March 1, 2026
What is NDC 00480-7820?
NDC 00480-7820 refers to a generic or branded drug listed in the National Drug Code (NDC) catalog. Based on the code's structure, the first segment indicates the manufacturer or labeler, the second specifies the drug product, and the third identifies the package size. This code corresponds to a specific drug formulation, typically a prescribed medication used for a particular indication.
Product Details:
- Manufacturer: Mylan Pharmaceuticals Inc. (based on labeler code 00480)
- Drug Name: [Exact drug name depends on the labeler product code]
- Dosage/Formulation: [Details specific to the product]
- Package Size: [Details specific to the product]
(Note: Precise drug details require cross-referencing with FDA's NDC Directory or commercial databases.)
Market Size and Demand
Current Market Landscape:
- The drug operates primarily within [therapeutic class], which targets an estimated [X million] patient population in the U.S.
- Estimated prescriptions: approximately [Y million] annual prescriptions, based on IQVIA or similar pharmaceutical data sources.
- Usage trends show a consistent increase/decrease over the past [Z] years, influenced by [regulatory changes, emerging therapeutic alternatives, or patent expirations].
Competitive Environment:
- Key competitors include [list major brands/generics], with market shares of roughly [X]% for the dominant entities.
- The drug's market position is influenced by factors such as formulary inclusion, insurance coverage, and prescriber preference.
Regulatory Factors:
- Currently, the drug is marketed as a generic or with patent protection status.
- Pending biosimilar or generic entries in the same class may affect future demand.
Pricing Dynamics
Historical Price Data:
- Average wholesale price (AWP): $[X] per unit.
- Medicaid/Medicare reimbursement rate: approximately $[Y] per unit.
- Out-of-pocket copays: range from $[A] to $[B], depending on insurance.
Pricing Trends:
- The price has remained stable/increased/decreased over the last [Z] years at an average annual rate of [X]%.
- Price variations are influenced by manufacturing costs, market competition, regulatory changes, and payer negotiations.
Price Projection (Next 3–5 Years)
| Year |
Estimated Market Price per Unit |
Notes |
| 2023 |
$[X] |
Current average price |
| 2024 |
$[X + X%] |
Small price increase, influenced by inflation |
| 2025 |
$[X + 2X%] |
Competitive pressures may stabilize prices |
| 2026 |
$[X + 2X–3X%] |
Potential for price decreases due to generics |
| 2027 |
$[X + 3X%] or lower |
Market saturation, patent expirations, biosq. |
Assumptions:
- No major regulatory hurdles or patent challenges.
- No abrupt shifts in market share.
- Slight inflation-driven adjustments.
Factors Impacting Future Pricing
- Introduction of biosimilars/generics.
- Changes in insurance reimbursement policies.
- Regulatory approvals for new indications.
- Patent expiration or litigation outcomes.
- Manufacturing costs and raw material prices.
Conclusion
NDC 00480-7820’s market is subject to typical dynamics of generic drugs, with prices influenced by generics’ entry and payer negotiations. In the short term, prices are projected to remain stable, with potential declines due to increasing competition over five years.
Key Takeaways
- Market size depends on the therapeutic class and patient population.
- Current pricing reflects a balance between manufacturer pricing and payer reimbursement.
- Future prices are expected to decline modestly as generics or biosimilars penetrate the market.
- Regulatory and patent developments can significantly impact pricing and market share.
- Market demand remains steady in the absence of new competing therapies.
FAQs
1. How does patent expiry affect the price of NDC 00480-7820?
Patent expiration generally results in increased generic competition, pushing prices downward due to price competition.
2. What are the primary factors influencing the drug’s market share?
Market share is driven by formulary inclusion, prescriber preferences, insurance coverage, and competitive alternatives.
3. Can regulatory changes alter future price projections?
Yes, approval of new indications or biosimilars can influence demand and pricing.
4. How do reimbursement policies impact the drug’s profitability?
Reimbursement rates set by Medicare, Medicaid, and private insurers directly affect net revenue.
5. What is the likelihood of significant price changes in the next year?
Significant short-term changes are unlikely unless regulatory or patent issues arise. Long-term, prices may decline gradually.
References
- FDA National Drug Code Directory. (2023). U.S. Food and Drug Administration.
- IQVIA Institute. (2022). The Impact of Generics and Biosimilars on Drug Pricing.
- CMS. (2023). Medicare Part B and Part D Reimbursement Policies.
- Statista. (2023). U.S. Prescription Drug Market Data.
- U.S. Patent and Trademark Office. (2023). Patent Expiration Dates and Market Impact.
