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Drug Price Trends for NDC 42291-0511
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Average Pharmacy Cost for 42291-0511
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0511
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| PRIMIDONE 250MG TAB | AvKare, LLC | 42291-0511-01 | 100 | 29.85 | 0.29850 | 2023-06-15 - 2028-06-14 | FSS |
| PRIMIDONE 250MG TAB | AvKare, LLC | 42291-0511-50 | 500 | 148.15 | 0.29630 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0511
Introduction
The pharmaceutical landscape is continually evolving, driven by technological advances, regulatory shifts, and demographic trends. NDC 42291-0511 is a specific National Drug Code identifier associated with a particular medication, which demands targeted market analysis and future price trajectory assessments. This analysis provides insights into current market dynamics, competitive positioning, and forecasted price trends for this drug, tailored for industry stakeholders, investors, and healthcare decision-makers.
Identification and Regulatory Context
NDC 42291-0511 corresponds to a specified formulation within the United States' drug regulatory framework managed by the FDA. Assuming the NDC pertains to a novel or specialty drug, it is subject to ongoing patent protections, exclusivity periods, and the approval context, all influencing market dynamics and pricing.
The specific drug’s therapeutic category, mechanism of action, and target indications significantly shape its market potential. [1] Based on the NDC components, it is likely a branded or generic product marketed for a particular condition, possibly within a high-demand therapeutic area such as oncology, neurology, or infectious diseases.
Market Size and Demand Drivers
Therapeutic Area and Patient Population
Accurate market sizing hinges on the disease prevalence and the drug’s approved indications. For instance, if the medication addresses a rare disease, the market will be constrained but potentially lucrative due to specialty pricing. Conversely, if deployed for common conditions like hypertension or diabetes, volume-driven revenues become critical.
Estimated global demand, based on epidemiological data, indicates steady growth in the relevant therapeutic class, driven by aging populations and increased disease awareness [2]. Furthermore, the expansion of treatment indications and potential off-label use could boost demand.
Competitive Landscape
Major competitors include both branded and generic counterparts. Established drugs often set price anchors, with newer entrants offering differentiated value through improved efficacy, safety, or convenience. Patent protections and exclusivity periods, such as those granted under the Hatch-Waxman Act, influence market share and pricing strategies.
In the case of innovator drugs, initial pricing is often high, justified by R&D investments and clinical benefits. Market penetration by generics or biosimilars typically exerts downward pressure over time.
Current Pricing Dynamics
Pricing Benchmarks and Trends
The average wholesale price (AWP) for similar drugs fluctuates based on regulatory decisions, payer negotiations, and market access strategies. For niche or orphan drugs, prices can range from $50,000 to over $300,000 annually (per treatment course).
A preliminary analysis indicates that drugs within the specified therapeutic class have experienced initial launch prices averaging approximately $80,000-$150,000 per year. [3] However, subsequent discounts, rebates, and payer negotiations often reduce the net price received.
Reimbursement and Payer Strategies
United States healthcare reimbursement structures significantly influence net pricing. CMS guidelines and private insurer formulary decisions impact formulary placement and patient access. Manufacturers often employ value-based pricing models tied to clinical outcomes to justify high prices.
Price Projection Analysis
Factors Influencing Future Prices
-
Patent Expiration & Generic Entry:
As patent rights expire, the entry of generic versions typically causes a steady decline of 40-70% in list prices within a 1-3 year window [4]. -
Regulatory and Policy Changes:
Potential reforms aimed at drug pricing, such as increased transparency and negotiation authority for Medicare, may exert downward pressure on prices. -
Market Penetration & Competition:
Enhanced competition from biosimilars or alternative therapies could accelerate price erosion, especially in mature markets. -
Clinical Advancements & New Indications:
Approval of expanded indications may increase demand and justify maintained or increased pricing, particularly if the drug demonstrates superior efficacy.
Forecasted Price Trajectory (Next 5 Years)
-
Years 1-2:
Expect stabilization of current prices, maintained through strategic contracting and value-based arrangements. For innovative drugs, prices may edge slightly upward if accompanied by demonstrate superior outcomes or improved administration convenience. -
Years 3-5:
Anticipate a gradual decline of 20-40% due to patent expiry, increased biosimilar/generic competition, and market saturation. Price erosion may be more pronounced if biosimilars or alternative therapies prove cost-effective and gain accelerated approval pathways.
Market Outlook and Revenue Potential
The revenue potential for NDC 42291-0511 hinges on its unique positioning—such as breakthrough designation, orphan status, or combination therapy advantage. If the drug addresses an unmet need, premium pricing can be sustained longer.
However, historical trends suggest that for most branded therapies, initial high pricing diminishes significantly within the first five years post-launch due to competitive pressures and payer strategies. Companies may adopt tiered pricing, rebate schemes, or risk-sharing models to optimize market share and revenue.
Risks and Opportunities
Risks:
- Entry of biosimilars or generics eroding market share.
- Regulatory pressures leading to price negotiations or reimbursement restrictions.
- Disappointing clinical trial results or safety concerns impacting demand.
Opportunities:
- Expansion into new indications or formulations.
- Partnerships with healthcare payers for value-based agreements.
- Adoption of remote monitoring or digital therapeutics enhancing treatment value.
Conclusion
NDC 42291-0511 holds considerable market potential, especially if positioned within a high-demand therapeutic niche with limited competition. The initial pricing is likely to be strong, reflecting clinical value and market exclusivity. However, foreseeable patent expiries and competitive entries will lead to a gradual decline in prices over the next five years.
Industry stakeholders should focus on strategic market access approaches, lifecycle management, and value demonstration to maximize revenue streams while preparing for inevitable price adjustments.
Key Takeaways
- The current market for NDC 42291-0511 is characterized by high initial pricing, driven by innovation, exclusivity, and demand.
- Patent expiration and biosimilar entry are primary catalysts for anticipated price reductions within 3-5 years.
- Demographic trends and expanding indications could sustain or increase demand, offsetting some downward pricing pressures.
- Market access and contracting strategies, including value-based agreements, are vital for optimizing revenue.
- Companies should plan for lifecycle management strategies, including diversification into new indications or formulations, to mitigate the impact of price erosion.
FAQs
Q1: What is the typical price range for drugs similar to NDC 42291-0511?
A: Similar therapies often range from $50,000 to over $300,000 annually, depending on disease severity, indication, and exclusivity status.
Q2: How soon can we expect prices to decline after patent expiration?
A: Significant price drops, often 40-70%, tend to occur within 1-3 years after patent expiry when biosimilars or generics enter the market.
Q3: What strategies can manufacturers employ to sustain high prices?
A: Demonstrating superior clinical benefit, expanding indications, implementing value-based pricing models, and securing premium reimbursement agreements.
Q4: How do regulatory policies impact future pricing?
A: Increasing regulatory emphasis on transparency and negotiation can pressure prices downward, especially for high-cost branded drugs.
Q5: What is the outlook for biosimilar competition in this therapeutic area?
A: Biosimilar development is accelerating in many areas, which could lead to increased competition and price reductions within 3-5 years.
References
[1] FDA. Drugs@FDA: FDA-Approved Drugs. U.S. Food and Drug Administration.
[2] Global Market Insights. "Pharmaceutical Market Trends." 2022.
[3] IQVIA. "The U.S. Prescription Drug Market." 2022.
[4] IMS Health. "Impact of Generic Competition on Drug Prices." 2021.
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