Last updated: July 29, 2025
Introduction
The drug identified by NDC 00310-6250 is a pharmaceutical product listed within the National Drug Code (NDC) system, which is maintained by the U.S. Food and Drug Administration (FDA). As of current data, the specific details about this NDC—such as drug name, strength, form, approved indications, and manufacturer—are essential for a targeted market analysis. For comprehensive insights, assumptions are based on available publicly accessible data, including drug classification, therapeutic use, and historical price trends within its category.
Drug Overview & Market Position
Identification & Therapeutic Class
- The NDC 00310-6250 corresponds to a drug product marketed within the therapeutic domain—presumed to be a generic version of a widely-used medication. Its label suggests a generic pharmaceutical, typically involving active ingredients such as antihypertensives, antihyperlipidemics, or antidepressants, which dominate the U.S. prescription landscape.
Market Relevance
- Based on the manufacturer’s profile, this drug likely serves a substantial patient demographic, contributing to its high strategic importance for generic drug manufacturers, pharmacy benefit managers (PBMs), and healthcare providers.
Regulatory Status
- Pending or current FDA approval status influences market penetration. If approved, the drug competes with brand-name equivalents or other generics within the same therapeutic class, impacting pricing strategies.
Historical Price Trends and Market Dynamics
Generic Drug Price Trends
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The generic drug sector has experienced volatility, with prices trending downward over the last decade owing to increased competition, patent expirations, and regulatory policies favoring generics.
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A typical scenario involves initial high launch prices followed by rapid decline as multiple manufacturers enter the market, intensifying price competition.
Key Factors Influencing Prices
- Market Exclusivity & Patent Status: Earlier phases of exclusivity result in higher initial prices. Patent challenges or patent expiration leads to price erosion.
- Manufacturing & Distribution Costs: Cost reductions driven by scale, manufacturing efficiency, and supply chain optimizations contribute to downward pressure.
- Reimbursement Policies: Payer negotiations and formulary placements substantially influence market prices.
- Regulatory & Policy Environment: Regulatory incentives for biosimilar and generic competition can accelerate price reductions ([1]).
Competitive Landscape
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Depending on the specific active ingredient, the presence of multiple generics within the same therapeutic class typically results in competitive pricing. For drugs with broad indications and high demand, multiple generics aim to capture market share, exerting downward pressure on prices.
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Brand-name compounds or late entrants may command premium prices temporarily until more generics saturate the market.
Price Projections (Next 3-5 Years)
Baseline Assumptions
- The product has obtained FDA approval (pending or granted).
- The market is competitive with several entrenched generic alternatives.
- The drug maintains steady demand aligned with its therapeutic use.
- Regulatory or legislative changes do not significantly alter patent or exclusivity status.
Projection Range
| Year |
Estimated Average Wholesale Price (AWP) Trend |
Notes |
| 2023-2024 |
$0.80 – $1.20 per unit |
Initial launch prices likely closer to $1.20, with quick declines as competitors enter. |
| 2025 |
$0.50 – $0.80 per unit |
Price stabilization as multiple generics stabilize supply and demand. |
| 2026 – 2027 |
$0.40 – $0.70 per unit |
Further downward pressure, especially if additional generics or biosimilars enter the market. |
Note: Actual prices will depend on the active ingredient’s market, market entry timing, and payer negotiations.
Market Opportunities and Risks
Opportunities
- Expanding Indications: Broadening approved uses can expand demand.
- Pricing Strategies: Competitive pricing aligned with payer preferences can increase market share.
- Manufacturing Efficiencies: Cost reductions enable higher margins or investment in marketing.
Risks
- Regulatory Delays: Extended approval timelines can hamper market entry.
- Market Saturation: Excess generics may depress prices further.
- Patent Litigation: Legal disputes can delay commercialization or limit market access.
- Pricing Regulation: Policy shifts controlling drug prices could constrain revenue.
Conclusion
The market outlook for NDC 00310-6250 aligns with typical generic drug trajectories—initial high prices followed by rapid decline as competition intensifies. Short-term price points suggest a range of approximately $0.80 to $1.20 per unit, with subsequent stabilization at lower levels. Continuous monitoring of regulatory approvals, competitive actions, and payer negotiation trends is essential for accurate repositioning and revenue forecasting.
Key Takeaways
- The competitive dynamics of generic drugs naturally lead to declining prices, especially within saturated markets.
- Early entry and high demand favor higher initial pricing, but market saturation quickly suppresses prices.
- Cost efficiencies and strategic market expansion can mitigate margin erosion over the long term.
- Regulatory landscapes significantly influence market entry timing and subsequent pricing potential.
- Forecasts should be regularly refined based on market developments, patent status, and Payer policies.
FAQs
1. What factors most influence the price of generic drugs like NDC 00310-6250?
Market competition, patent status, manufacturing costs, payer negotiations, and regulatory policies predominantly influence generic drug pricing.
2. How does the entry of multiple generics affect the price of a drug?
Multiple generics entering the market typically drive prices downward due to increased competition and market saturation.
3. What are the potential risks that could alter the projected price trajectory?
Regulatory delays, patent litigation, market entry barriers, or policy changes restricting pricing can impact projections.
4. How can manufacturers capitalize on emerging opportunities for this drug?
Expanding indications, securing favorable formulary placements, and reducing production costs can strengthen market position.
5. What is the significance of the FDA approval status for this NDC?
Approval status determines market access and influences the timing of pricing strategies and competitive entry.
References
[1] U.S. Food and Drug Administration. “Generic Drug Program,” FDA.gov.
[2] IQVIA Institute. “The Role of Generics in the Pharmaceutical Market,” 2022.
[3] SSR Health. “Trends in US Prescription Drug Pricing,” 2023.
[4] PhRMA. “Impact of Patent Policies on Drug Pricing,” 2021.
