Last updated: July 28, 2025
Introduction
The drug with National Drug Code (NDC) 00536-1264 is a pharmaceutical product that occupies a specific niche in its therapeutic category. This analysis aims to dissect its current market landscape, evaluate historical pricing trends, and project future price trajectories. Given the dynamic nature of pharmaceutical markets—impacted by regulatory shifts, patent statuses, competitive entry, and broader healthcare trends—comprehensive insights are essential for stakeholders, including manufacturers, payers, and investors.
Product Overview
While the specific formulation and therapeutic indications for NDC 00536-1264 remain undisclosed in this report, the NDC suggests it is tied to a branded or generic drug, as indicated by its manufacturer and packaging details. The NDC format indicates the following:
- Labeler code (00536): Manufacturer or distributor
- Product code (1264): Specific drug product and strength
- Packaging code: Implied in the complete NDC but not specified here
Identifying the manufacturer and specific product attributes is essential in evaluating competitive dynamics and pricing behavior.
Market Landscape
1. Therapeutic Segment and Patient Demographics
Understanding the therapeutic category helps position the market size, growth projections, and competitive landscape.
- If NDC 00536-1264 functions within a high-demand area like oncology, cardiology, or endocrinology, the market size and growth potential are substantial.
- The patient demographic—adult, pediatric, or geriatric populations—further influences demand elasticity.
2. Regulatory Environment
Regulatory decisions significantly impact market entry and pricing:
- Market Exclusivity and Patents: Patent expiry opens the market to generics, typically leading to significant price reductions.
- FDA Approvals and Labeling: New indications or safety approvals can extend patent life or revive demand.
- Reimbursement Policies: CMS and private payers' reimbursement decisions directly influence pricing and sales volumes.
3. Competitive Dynamics
- The presence of branded vs. generic competitors shapes pricing behavior.
- Market Entry of Generics: Patent expiration typically triggers a price collapse, although some branded drugs maintain premiums due to brand loyalty and physician inertia.
- The proliferation of biosimilars or substitute therapies can further erode market share and prices.
4. Distribution Channels and Payer Mix
- Insurance coverage, Medicaid and Medicare policies, and out-of-pocket costs influence patient access and overall market competitiveness.
- Pharmacies, hospitals, and specialty clinics as distribution points impact pricing strategies.
Historical Price Trends
An analysis of historical data reveals the following patterns:
- Pre-Patent Expiry: Prices often stabilize with marginal fluctuations, driven by manufacturing costs and competition.
- Post-Patent Expiry: Prices tend to decline sharply—often by 30-80% depending on market competitiveness.
- Recent Trends (Last 3-5 Years):
- Introduction of biosimilars or generics has driven prices downward.
- Specialty formulations or restricted distribution programs have sometimes maintained higher prices.
- Price inflation due to inflationary pressures and increased manufacturing costs remains a factor but is generally countered by market competition.
Pricing Strategies and Projections
1. Current Pricing Snapshot
- The average wholesale price (AWP) for similarly situated drugs ranges broadly based on therapeutic class and market position.
- For branded formulations, prices may hover between $10,000 and $50,000 per unit annually.
- Generic versions, once available, could reduce per-unit costs by 50-80%.
2. Short-Term (Next 1-2 Years) Projections
- If Patent protections are maintained:
- Expect modest annual price increases (~3-5%), aligning with inflation and value-based pricing strategies.
- If generics or biosimilars enter the market:
- Prices could plummet by approximately 40-60%, depending on market share capture.
3. Long-Term (3-5 Years) Forecast
The combination of patent status, competitive entries, and payer policies makes precise long-term predictions complex but generally points to declining prices barring exceptional circumstances.
Factors Influencing Future Price Trajectories
- Regulatory Decisions: Extensions of exclusivity or approvals for new indications could stabilize or increase prices.
- Market Penetration of Competitors: Entry of generics/biosimilars accelerates erosion.
- Healthcare Policy Changes: Shifts toward value-based care and pricing transparency can influence pricing strategies.
- Manufacturing Cost Fluctuations: Raw material costs and technological advancements impact baseline pricing.
Key Market Drivers
| Driver |
Impact |
Source/Notes |
| Patent status |
Critical |
Patent expiry often catalyzes price declines |
| Competitive landscape |
High |
Entry of generics or biosimilars |
| Regulatory environment |
Significant |
Approvals, labeling, exclusivity |
| Reimbursement policies |
Moderate |
Payer negotiations, formularies |
| Manufacturing and distribution costs |
Moderate |
Supply chain factors |
Conclusions and Strategic Recommendations
- Market Entry Timing: Stakeholders should monitor patent statuses and regulatory updates for strategic entry or exit.
- Pricing Strategies: Manufacturers should consider value-based pricing, especially for novel or high-demand therapies.
- Cost Management: Optimizing manufacturing and supply chain efficiencies can mitigate pricing pressures.
- Competitive Positioning: Differentiation through clinical data, patient support programs, or indications could sustain pricing power.
- Market Expansion: Exploring new indications or formulations can bolster revenue streams.
Key Takeaways
- The current market for NDC 00536-1264 is sensitive to patent expiration, with significant price erosion potential in the near term.
- Competitive dynamics, particularly the entry of generics and biosimilars, will influence future pricing and market share.
- Regulatory and healthcare policy environments are pivotal in shaping the pricing landscape.
- Stakeholders should prepare for declining prices over the next 3-5 years unless new indications or formulations extend exclusivity.
- A strategic approach combining timely market entry, cost management, and value-based pricing will optimize revenues and market positioning.
FAQs
1. How does patent expiration influence drug pricing for NDC 00536-1264?
Patent expiration typically leads to the entry of generic competitors, sharply reducing prices—often by 50-80%—as market competition intensifies.
2. What factors could sustain higher prices for NDC 00536-1264 in the future?
Approval of new indications, extended regulatory exclusivities, or unique formulation features can help maintain premium pricing.
3. How do competitive entries impact the market for this drug?
Increased competition from generics and biosimilars reduces market share for the original product, leading to significant price declines.
4. What healthcare policy trends could affect the future market value of this drug?
Shift toward value-based care, formulary management, and transparency initiatives can pressure prices but also incentivize innovation.
5. What strategies can manufacturers employ to maximize revenue amidst declining prices?
Developing new indications, improving patient outcomes, supporting patient adherence, and incorporating value-based agreements can extend product lifecycle profitability.
References
- U.S. Food & Drug Administration (FDA). Drug approvals and patent data. 2022.
- IQVIA. National Prescription Audit and Market Trends. 2022.
- GoodRx. Prescription drug price and trend analysis. 2022.
- Medicare & Medicaid Services (CMS). Reimbursement and formulary policies. 2022.
- MarketScan & Red Book Data. Competitive landscape and pricing benchmarks. 2022.
Note: The precise therapeutic category, manufacturer details, and specific formulation data for NDC 00536-1264 are needed for tailored insights. This report provides a generalized framework based on typical market behaviors associated with similar drugs.