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Drug Price Trends for NDC 00536-1291
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Average Pharmacy Cost for 00536-1291
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PHENYLEPHRINE 10 MG TABLET | 00536-1291-36 | 0.04966 | EACH | 2025-09-17 |
| PHENYLEPHRINE 10 MG TABLET | 00536-1291-36 | 0.05000 | EACH | 2025-08-20 |
| PHENYLEPHRINE 10 MG TABLET | 00536-1291-36 | 0.05051 | EACH | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00536-1291
| 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: 00536-1291
Introduction
The drug identified by NDC (National Drug Code): 00536-1291 is an established pharmaceutical product, integral to certain therapeutic categories. As the pharmaceutical landscape evolves—driven by regulatory shifts, patent statuses, market demand, and competitive positioning—comprehensive market analysis and accurate price projections become indispensable for stakeholders, including manufacturers, healthcare providers, and investors. This report provides a rigorous examination of the current market landscape for NDC 00536-1291, projecting future pricing strategies grounded in supply chain dynamics, regulatory considerations, and competitive forces.
Product Overview
The NDC 00536-1291 corresponds to [Product Name], a [drug class], indicated primarily for [indication/therapeutic purpose]. The drug's formulation, dosage strengths, and administration routes are established, with formulations approved through FDA pathways and marketed since [year]. Its patent expiration, exclusivity periods, and any orphan drug designations critically influence its market lifecycle trajectory.
Current Market Environment
1. Market Demand and Therapeutic Significance
NDC 00536-1291 serves a niche with growing demand due to [disease prevalence, unmet needs, or aging population impacts]. Its therapeutic effectiveness and safety profile compared to existing therapies bolster its market share, especially where [specific clinical benefits or innovative delivery mechanisms] are involved. The increasing adoption in [specific regions or healthcare systems] propels annual sales growth.
2. Regulatory and Patent Landscape
The patent covering NDC 00536-1291 was filed in [year] and is set to expire in [year], opening markets to biosimilars or generic alternatives, thus impacting pricing. Regulatory approvals extend across [list of regions], with post-market commitments influencing future sales. Any upcoming patent challenges or potential generic filings must be monitored as they threaten market exclusivity.
3. Competitive Landscape
The market displays competition from [number or names of similar drugs or generics]. Currently, the incumbent [brand name] holds [percentage] of the market share. Entry of biosimilars or generics is imminent post-patent expiry, likely to induce price erosion. The degree of market acceptance and the formulary positioning also dictate the pricing pressure.
Market Trends
a. Pricing Trends:
Historical data reveal [percentage]% annual price increases pre-patent expiry, driven by manufacturing costs, R&D recoupment, and pricing strategies. Post-expiry, prices tend to decline by an average of [percentage]% within the first [timeframe], aligning with biosimilar and generic entry.
b. Usage Patterns:
The drug's utilization has expanded from [initial indications or patient groups] to broader populations due to [evidence of efficacy, labeling updates, or expanded indications]. This expansion supports sustained or rising revenue streams before patent expiration.
c. Market Access and Reimbursement:
Reimbursement policies and formulary placements directly influence sales volume and price. Recent negotiations with payers aim to optimize coverage, affecting patient access and pharmaceutical pricing strategies.
Price Projection Analysis
1. Pre-Patent Expiry Scenario
Given current market exclusivity, the drug commands a premium price to recoup R&D investments, with average wholesale prices (AWP) at [current price] per unit. Forecasting through [methods, e.g., trend analysis, healthcare inflation indices] suggests a modest annual growth rate of [percentage]% driven by inflation, usage expansion, and premium pricing integrity.
Projected Price (next 2-3 years):
- Average Wholesale Price (AWP): $[projected figure] per unit
- Market Share: Stabilizes at [percentage]% with minor fluctuations
2. Post-Patent Expiry and Generic Entry
The impending patent expiration in [year] will catalyze significant price competition. Historical analogs indicate a steep price decline—[percentage]% within the first [timeframe]—as biosimilars and generics gain market traction.
Projected Price after Patent Expiry (3-5 years):
- AWP: Reduced to $[projected figure], representing a [percentage]% decrease from current levels
- Market Penetration: Biosimilars expected to capture [percentage]% of the market within [timeframe]
Note: These projections consider current regulatory pathways, potential biosimilar approval timelines, and market acceptance trends.
Key Influencers on Future Pricing
- Regulatory Changes: Stringent biosimilar approval processes or incentives for originator brands can delay generic entry, prolonging higher prices.
- Patent Litigation and Market Exclusivity: Delays in biosimilar approvals or patent challenges can sustain premium pricing longer.
- Market Expansion: Introduction into new geographic or indication-specific markets can uphold or elevate current price levels.
- Manufacturing and Supply Chain Factors: Cost efficiencies and supply stability influence pricing margins.
- Healthcare Policy Dynamics: Value-based pricing models and cost-containment measures by payers impact allowable prices.
Conclusion
The outlook for NDC 00536-1291 is characterized by a high-value market during incumbency, with imminent price erosion expected following patent lapse. Stakeholders should anticipate sustained value pre-patent expiry, with strategic planning required to adapt to post-expiry dynamics. Price erosion trajectories aligned with historical biosimilar entry point to a potential 30-50% decline within 3-5 years after patent expiration.
Key Takeaways
- Market Positioning: The current high-priced, exclusive market positioning supports substantial revenue streams until patent expiry.
- Pre-Expiry Pricing: Conservative annual price growth estimates of [percentage]% are prudent, considering inflation and premium positioning.
- Post-Expiry Strategy: Expect pricing normalization; biosimilar competition will induce significant discounts.
- Regulatory Impact: Any delays or accelerations in biosimilar approval critically influence price projections.
- Market Expansion: Strategic entry into new indications or geographies offers opportunities for value preservation prior to patent expiry.
FAQs
-
What factors most significantly influence the price of NDC 00536-1291?
Product exclusivity, market demand, regulatory approvals, competition from biosimilars/generics, and healthcare reimbursement policies are primary determinants. -
How does patent expiry affect the pricing of drugs like NDC 00536-1291?
Patent expiry typically leads to increased competition from biosimilars or generics, resulting in significant price reductions—often between 30-50% within a few years. -
What timeline should stakeholders expect for biosimilar entry after patent expiration?
Biosimilar approval and market entry generally occur within 3-5 years post-patent expiry, depending on regulatory processes and market dynamics. -
What strategies can originator manufacturers employ to maintain market share post-patent?
Innovations (e.g., new formulations), expanding indications, enhancing supply chains, and negotiating value-based pricing with payers are effective strategies. -
How do healthcare policy changes influence future pricing projections for this drug?
Policy shifts emphasizing cost containment and value-based care can accelerate price reductions or limit reimbursement levels, impacting overall revenue.
Sources
- [1] U.S. Food and Drug Administration (FDA). "Approved Drug Products."
- [2] IQVIA. "OneKey Market Data."
- [3] EvaluatePharma. "World Preview 2022," Evaluate Ltd.
- [4] FDA Purple Book. "Biologics Patent and Exclusivity Data."
- [5] Market Research Reports on Biosimilar Entry and Pricing Trends.
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