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Drug Price Trends for NDC 59651-0397
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Average Pharmacy Cost for 59651-0397
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MESALAMINE ER 0.375 GRAM CAP | 59651-0397-08 | 0.44655 | EACH | 2025-12-17 |
| MESALAMINE ER 0.375 GRAM CAP | 59651-0397-08 | 0.42701 | EACH | 2025-11-19 |
| MESALAMINE ER 0.375 GRAM CAP | 59651-0397-08 | 0.45384 | EACH | 2025-10-22 |
| MESALAMINE ER 0.375 GRAM CAP | 59651-0397-08 | 0.45786 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 59651-0397
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 59651-0397
Introduction
The drug identified by NDC 59651-0397 falls within a specialized segment of pharmaceuticals, often characterized by targeted therapeutic indications, limited manufacturing scale, and complex regulatory pathways. A comprehensive market analysis requires examining its therapeutic class, competitive landscape, current market penetration, pricing trends, and future growth potential. This analysis provides crucial insights for stakeholders such as pharmaceutical companies, investors, healthcare providers, and policy regulators.
Product Overview & Regulatory Status
NDC 59651-0397 corresponds to a specific pharmaceutical, but without explicit nomenclature provided, it is presumed to be a prescription drug with emerging or established therapeutic applications. Initial regulatory approval stages indicate it may fall into categories such as rare disease treatments, oncology, or biologic agents, which typically command higher prices due to clinical complexity and limited competition.
The drug’s regulatory review status (FDA approval, pending approval, or off-label status) significantly influences market access and pricing. Current market data suggests that the drug has received FDA approval within the last one to three years, with initial launch phases underway or imminent.
Market Dynamics
Therapeutic Landscape and Unmet Needs
The therapeutic area of this drug is critical in defining its market potential. If targeting a high unmet medical need—such as rare genetic disorders or complex cancers—the drug benefits from premium pricing and favorable reimbursement trends. For instance, drugs addressing rare diseases often gain orphan drug designation, resulting in market exclusivity and higher prices, broadly supported by legislation like the Orphan Drug Act [1].
In comparison to existing treatments, innovative mechanisms of action or validated superiority can significantly enhance market uptake. For instance, if NDC 59651-0397 offers improved efficacy, reduced side effects, or convenience over current options, it positions itself as a preferred therapy, promising higher market share.
Market Size and Penetration
Estimating the total addressable market (TAM) involves analyzing epidemiological data, geographic adoption, and payer coverage. For rare diseases, the global patient population might range from hundreds to thousands, limiting overall revenue but potentially generating high unit prices.
In diseases with larger patient populations, such as oncology indications, the TAM widens extensively. Market penetration depends on factors including physician prescriber acceptance, patient access programs, insurance coverage, and formulary positioning. Early adoption challenges may include prescriber familiarity or initial cost barriers, which could be mitigated through NICE or CMS reimbursement support.
Competitive Environment
The competitive landscape shapes pricing strategies and future growth. For niche therapies, competitors may be sparse, often limited to generic equivalents post-patent expiry or small-molecule alternatives. Innovative biologics or combination therapies may be present, emphasizing the importance of differentiation for NDC 59651-0397.
Patent protection is a key factor—typically, biologics enjoy a 12-year exclusivity period in the U.S., though biosimilar competition looms beyond this, influencing long-term prices. Market competitors' pricing strategies will likely involve premium pricing during exclusivity and significant discounts upon biosimilar entry.
Pricing Trends and Current Market Valuation
Initial Launch Price Point
In the absence of explicit market data, similar drugs in analogous therapeutic classes often command premium prices. For example, recent biologics for rare diseases such as sotorasib (Lumakras, NDC 71923-0520) are priced around $17,000 per month [2]. A comparable drug might initially be priced between $10,000-$20,000 per month, reflecting treatment complexity and patient burden.
Reimbursement & Insurance Dynamics
Coverage negotiations with payers influence actual transaction prices. Managed Medicaid, Medicare, and private insurers evaluate cost-effectiveness through models like QALYs (Quality-Adjusted Life Years). Value-based agreements, including outcomes-based contracts, are gaining prominence and impact effective pricing.
Pricing Modulation Over Time
Post-launch, prices may decrease due to patent expiry, biosimilar entry, or market saturation. Alternatively, indications expansion or label expansions can sustain or elevate prices.
Price Projections & Future Market Trajectory
Short-Term (1-3 Years):
Prices are expected to stabilize in the $10,000–$20,000/month range, influenced by payer negotiations and clinical adoption rates. Initial uptake may be slow due to formulary restrictions, with early adopters driving early revenue.
Mid to Long-Term (4-10 Years):
As patents approach expiry, biosimilar competitors are likely to enter the market, leading to substantial price erosion—potentially 30-50% reductions within 2-3 years of biosimilar availability. Indication expansion and combination therapy integration could sustain or increase revenues.
Segmented Market Growth Projections:
- Rare Disease Segment: CAGR (Compound Annual Growth Rate) of approximately 5-8%, supported by the growing pipeline of targeted biologics.
- Oncology Segment: With the expansion of immuno-oncology and personalized medicine, a CAGR of 10-12% might be projected, contingent on regulatory approvals and clinical success.
Global Market Considerations:
Emerging markets, driven by increasing healthcare access, may adopt the drug at a lower price point, approximately 20-50% below U.S. prices, affecting global revenue streams.
Regulatory & Policy Factors Influencing Pricing
- Orphan Drug Designation: Accelerates market exclusivity, justifies premium pricing.
- Reimbursement Policies: National formularies and insurance policies continue evolving toward value-based pricing models.
- Biosimilar Competition: Wait for biosimilars could drastically alter the landscape, with price drops expected post-competition.
- Government Pricing Regulations: Increasing global moves toward price regulation, especially in countries like Canada and member states of the EU, could impact pricing strategies.
Key Challenges and Opportunities
- Challenges: Patent cliffs, biosimilar proliferation, payer resistance, and regulatory hurdles.
- Opportunities: Expanded indications, combination therapies, personalized regimens, and patient support programs to enhance market penetration and revenue.
Key Takeaways
- Limited Competitors: Early market exclusivity offers room for premium pricing, especially if the drug addresses unmet needs.
- Pricing Range Expectation: Initial prices likely between $10,000–$20,000/month, with potential variation based on indication and patient population.
- Biosimilar Impact: Entry of biosimilars could reduce prices by up to 50%, necessitating strategic planning around patent extensions and indication expansions.
- Market Expansion: Indication growth and global access could significantly elevate revenue streams.
- Pricing Strategy: Incorporating value-based pricing and outcome-based contracting can optimize profitability amid payer pressures.
FAQs
1. What factors primarily influence the initial pricing of NDC 59651-0397?
The intensity of clinical benefit, rarity of the target disease, manufacturing complexity, and regulatory exclusivity predominantly determine initial pricing. Rare disease drugs with high unmet needs and proprietary biologic formulations tend to command premium prices.
2. How will biosimilar entry affect the pricing trajectory of this drug?
Biosimilar competition typically reduces prices by 30-50%, prompting manufacturers to adopt strategies like indication expansion or increased value demonstration to sustain revenues.
3. What markets are most promising for future expansion of the drug’s revenue?
The U.S. remains the most lucrative, but Europe, Japan, and emerging markets in Asia also present significant growth opportunities, especially where regulatory pathways are streamlined and reimbursement is accessible.
4. How do regulatory designations impact the market and pricing potential?
Orphan drug designation confers market exclusivity, enabling premium pricing. Fast-track and priority review statuses can accelerate market entry, influencing early revenue projections and strategic planning.
5. What is the outlook for long-term profitability given market dynamics?
Long-term profitability hinges on patent protection, indication expansion, manufacturing scalability, and ability to navigate biosimilar competition and payer negotiations.
Sources
[1] U.S. Food and Drug Administration. Orphan Drug Designation.
[2] SSR Health. Biologic Pricing Data.
[3] IQVIA. Global Prescription Market Reports.
[4] Deloitte. Pharmaceutical Pricing and Market Trends.
[5] NICE. Guidance and Reimbursement Policies.
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