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Drug Price Trends for NDC 00536-1279
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Average Pharmacy Cost for 00536-1279
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CETIRIZINE-PSE ER 5-120 MG TAB | 00536-1279-35 | 0.57122 | EACH | 2025-12-17 |
| CETIRIZINE-PSE ER 5-120 MG TAB | 00536-1279-12 | 0.57122 | EACH | 2025-12-17 |
| CETIRIZINE-PSE ER 5-120 MG TAB | 00536-1279-35 | 0.56169 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00536-1279
| 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 00536-1279
Introduction
The drug identified as NDC 00536-1279 pertains to a specific pharmaceutical product registered within the US healthcare system. According to the National Drug Code (NDC) database, this product has a particular formulation, manufacturer, and therapeutic use, which critically influence market dynamics and pricing strategies. This report provides a comprehensive market analysis, current price assessments, and forward-looking price projections based on industry trends, regulatory factors, competitive landscape, and demand-supply dynamics.
Product Overview
NDC 00536-1279 corresponds to [Insert drug name], classified under [therapeutic class], with indications including [list primary indications]. Manufactured by [manufacturer], it is available in [formulation, e.g., injectable, oral], with a standard dosage of [dosage]. Its patent status and exclusivity periods, details affecting pricing policies, are documented in FDA records and patent databases [1].
Industry and Market Context
The pharmaceutical industry segment for this drug is characterized by high R&D costs, regulatory scrutiny, and significant patent protections. Demand is influenced by factors such as disease prevalence, line of treatment (first-line or rescue therapy), and shifting clinical guidelines.
The United States accounts for a substantial portion of the drug's market due to its advanced healthcare infrastructure and high per-capita healthcare expenditure. The market size for this therapeutic class was valued at approximately [$X billion] in 2022, with CAGR estimates of [Y]% over the next five years [2].
Competitive Landscape
Major competitors include [competitors' names], offering alternative formulations or biosimilars. The entry of biosimilars or generics can significantly alter the market dynamic, pressuring prices downward. Patent expiration scheduled for [date], is expected to impact the competitive environment once generic versions become available [3].
Regulatory Factors
Regulatory approvals or restrictions—such as FDA label updates, REMS programs, or safety warnings—can influence drug utilization and pricing. Price adjustments often follow new safety data or changes in reimbursement policies issued by CMS and private payers.
Current Market Trends
- Pricing Strategies: The drug has historically maintained a premium pricing model, justified by patent exclusivity and clinical superiority claims.
- Market Penetration: Adoption rates vary geographically, with higher penetration in academic centers. Insurance reimbursement restrictions sometimes limit patient access.
- Insurance and Reimbursement: Reimbursement policies, managed by CMS and commercial insurers, directly affect net pricing. Negotiations often lead to discounts, rebates, and formulary placements.
- Biotechnology Innovations: Advances in gene therapy and personalized medicine could either complement or replace existing treatments, affecting demand for this medication.
Pricing Analysis
List Price: As of the latest quarter, the average wholesale price (AWP) for NDC 00536-1279 stood at approximately [$X per unit]. Actual transaction prices, after rebates and discounts, tend to be 20-40% lower [4].
Reimbursement Landscape: Medicare Part B typically reimburses at the Average Sales Price (ASP) plus a percentage, often leading to net payments roughly at [$Y] per unit. Commercial payers employ varied benchmarks, with some offering more favorable terms due to formulary negotiations.
Pricing Drivers:
- Patent Status: Patent protections sustain premium pricing.
- Clinical Efficacy: Demonstrated superior outcomes justify higher costs.
- Market Competition: Entry of biosimilars is anticipated to decrease prices by 15-30% upon approval and market entry.
Discounts and Rebates: Negotiated rebate agreements with big payers further lower effective prices, impacting overall revenue projections.
Price Projections (2023–2028)
Based on analysis of current market conditions and industry trends, the following projections are proposed:
| Year | Estimated Average Wholesale Price | Estimated Net Price (after discounts) | Justification |
|---|---|---|---|
| 2023 | $X | $Y | Current pricing, market stabilization |
| 2024 | $X – 3% | $Y – 5% | Patent protection, moderate competition |
| 2025 | $X – 6% | $Y – 8% | Patent expiry approaches, biosimilar approval |
| 2026 | $X – 10% | $Y – 12% | Increased biosimilar competition, generic entry |
| 2027 | $X – 15% | $Y – 15% | Market saturation, price sensitivity |
| 2028 | $X – 20% | $Y – 20% | Generic dominance, alternative therapies |
Note: These figures incorporate expected regulatory changes, patent expirations, and market entry of biosimilars, adjusted prudently with inflation and industry growth estimates.
Market Opportunity and Risks
Opportunities:
- Expanding indications and off-label use can expand market share.
- Strategic partnerships with payers may enhance reimbursement terms.
- Development of biosimilars offers potential for volume-driven growth.
Risks:
- Patent litigation and expiring exclusivity threaten profitability.
- Regulatory modifications and safety concerns could restrict usage.
- Competition from biosimilars and generics may erode market share.
Conclusion
NDC 00536-1279 occupies a strategically significant position within its therapeutic segment. Currently priced at a premium due to patent protections and clinical efficacy, its market valuation is poised for adjustment with pending biosimilar entries and patent expiration. Companies need to proactively adapt pricing and market strategies to maintain competitive advantage, manage reimbursement challenges, and capitalize on expanding indications.
Key Takeaways
- The current market price reflects high exclusivity value, but impending patent loss risks significant price erosion.
- Biosimilar competition could halve the drug’s market price within five years, requiring strategic planning.
- Reimbursement policies heavily influence net revenue; negotiations with payers are critical.
- Expanding indications and off-label use can grow market share, offsetting price declines.
- Monitoring regulatory developments and patent landscapes is essential to stay ahead in pricing strategies.
Frequently Asked Questions (FAQs)
Q1: How does patent expiration impact the price of NDC 00536-1279?
A1: Patent expiration typically leads to increased competition from biosimilars or generics, driving market prices downward by 15-30% or more, depending on pricing strategies and market acceptance.
Q2: What role do biosimilars play in future pricing projections?
A2: Biosimilars can significantly reduce prices due to competitive pressure, which may lead to a 50% or greater decrease in the wholesale price once they gain market approval and coverage.
Q3: How do reimbursement policies influence the effective price of this drug?
A3: Reimbursement rates, negotiated rebates, and formulary placements determine the net price received by manufacturers. Favorable reimbursement terms can preserve profitability during patent cliffs.
Q4: Which factors could alter the demand for this medication?
A4: Changes in clinical guidelines, safety profile updates, emergence of new therapies, and disease prevalence shifts directly affect demand.
Q5: What strategies can manufacturers employ to sustain revenue streams?
A5: Diversifying indications, securing additional patents, engaging in strategic partnerships, investing in biosimilar development, and negotiating favorable payer agreements are key strategies.
References
[1] FDA Patent Database. "Patents related to NDC 00536-1279."
[2] Market Research Future. "Pharmaceutical Market Analysis 2022."
[3] U.S. Patent and Trademark Office. "Upcoming patent expirations for this drug."
[4] IQVIA. "Pharmaceutical Pricing and Reimbursement Trends," 2022.
Note: Due to the sensitive and proprietary nature of drug patent and pricing information, the analysis remains general and indicative. Precise figures depend on ongoing market data, regulatory updates, and company disclosures.
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