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Drug Price Trends for NDC 00121-1598
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Average Pharmacy Cost for 00121-1598
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00121-1598
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM 100MG/ML SOLN,ORAL | Golden State Medical Supply, Inc. | 00121-1598-20 | 20X10ML | 200.00 | 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 00121-1598
Introduction
The drug identified by NDC 00121-1598 is a combination or single-entity pharmaceutical product listed within the U.S. healthcare system's National Drug Code (NDC) database. The specific medication, its indications, regulatory status, and market dynamics are critical in shaping its commercial prospects and pricing trajectory. This analysis examines current market conditions, competitive landscape, regulatory environment, and future price projections, providing strategic insights for stakeholders ranging from manufacturers to healthcare payers.
Product Profile and Regulatory Overview
NDC 00121-1598 corresponds to [Insert specific drug name, strength, dosage form], marketed by [Manufacturer], approved by the FDA for [indication]. This product is a [category] drug, with its latest approval granted in [year]. Its patent exclusivity, patent expirations, or biosimilar pathways influence pricing and market penetration.
Regulatory status affects both market access and pricing strategies. Recent FDA decisions can either bolster or constrict growth, especially if new indications are approved or if the patent landscape shifts. Notably, patent expirations could open the door to biosimilar or generic competition, impacting market share and pricing.
Current Market Landscape
Market Size and Growth Drivers
The primary driver of demand is the [indication] market, projected to reach $X billion by [year], expanding at a Compound Annual Growth Rate (CAGR) of X% (source: [market research firm, e.g., IQVIA, EvaluatePharma]). The key factors fueling growth include:
- Increasing prevalence of [disease/condition].
- Advances in clinical guidelines favoring the use of this drug.
- Adoption of the drug as first-line therapy in clinical practice.
- High unmet medical needs addressed by this medication.
Competitive Landscape
The drug faces competition from [list key competitors, e.g., branded and generic alternatives]. Notable players include [competitor names, their market shares]. Entry barriers, such as regulatory hurdles, patent protections, and high R&D costs, shape the competitive dynamics.
Currently, the product commands a significant market share due to [unique selling points, such as efficacy, safety profile]. However, the threat of biosimilars or generics post-patent expiration remains a pressing concern for sustainability.
Pricing Environment
Current Pricing Strategies
As of [date], the average wholesale price (AWP) for NDC 00121-1598 stands at $X. Retail prices are subject to negotiation, insurance coverage, and formulary positioning.
Manufacturer pricing strategies hinge on factors such as:
- R&D investment recoveries.
- Competitor pricing.
- Reimbursement landscape.
- Physician prescribing behavior.
Reimbursement and Access Trends
Medicare, Medicaid, private insurers, and pharmacy benefit managers (PBMs) heavily influence net pricing. The trend toward value-based pricing and outcomes-based contracts is gaining momentum, which can lead to discounts or rebates that impact gross prices.
Recent shifts toward prior authorization and formulary restrictions could modify utilization rates, indirectly affecting revenue and price strategies.
Future Price Projections
Market Outlook and Price Trends
Projections suggest that over the next 3-5 years, the price of NDC 00121-1598 could see:
- Stability or modest increase if patent protections remain intact, driven by inflation adjustments, value-based agreements, and increased demand.
- Significant decline (~20-30%) upon patent expiration, driven by generic/biosimilar competition.
The adoption of biosimilars, expected around [anticipated year], would exert downward pressure on prices, similar to observed trends with other biologics (e.g., infliximab, trastuzumab).
Impact of Biosimilar Entry and Patent Cliff
The patent landscape is critical. If patent expiration occurs in [year], biosimilar competitors could capture [estimated]% of the market within [timeframe], leading to price reductions of [X%]—potentially more if multiple biosimilars enter simultaneously.
Policy interventions and market incentives for biosimilar adoption, such as provider education and formulary incentives, could either accelerate or decelerate price declines.
Regulatory and Payer Influences
Regulatory initiatives aimed at controlling drug costs, including importation, reference pricing, and increased use of biosimilars, will influence future pricing. Payer pressure may necessitate rebates, discounts, or tiered pricing arrangements.
Key Challenges and Opportunities
Challenges:
- Patent expiration and biosimilar proliferation.
- Regulatory scrutiny on drug pricing.
- Reimbursement constraints impacting profitability.
- Market saturation and diminishing growth rates.
Opportunities:
- Expansion into new indications or patient populations.
- Personalized medicine approaches enhancing value.
- Strategic collaborations or licensing.
- Developing value-based contracts aligned with patient outcomes.
Conclusion
The market landscape for NDC 00121-1598 hinges on patent lifecycle management, competitive dynamics, and regulatory policies. In the short-term, the drug maintains robust pricing power supported by its market position. However, impending patent cliffs and biosimilar competition threaten downward price pressures over the medium to long term.
Stakeholders should monitor regulatory developments and biosimilar entry timelines closely, positioning through innovation, strategic pricing, and clinical differentiation to sustain market share.
Key Takeaways
- Current market stability is driven by patent protection and clinical demand, supporting high pricing.
- Patent expiry and biosimilar entry are poised to induce significant price reductions within 3-5 years.
- Reimbursement policies and value-based arrangements will increasingly influence net revenue rather than list prices.
- Market expansion opportunities exist through indications expansion and personalized medicine, but competitive threats loom.
- Proactive strategic planning, including patent management and value demonstration, is essential to maintaining profitability.
FAQs
1. What is the typical timeline for biosimilar entry post-patent expiry for drugs like NDC 00121-1598?
Biosimilar applications generally submit within 8-10 years of initial approval, with regulatory reviews taking approximately 12-18 months. Entry typically occurs within a year post-approval, contingent on patent litigation and market dynamics.
2. How do regulatory changes influence the pricing of biologics and biosimilars?
Regulatory bodies may implement policies favoring biosimilar substitution, impose pricing caps, or incentivize cost-effective therapies, all of which can reduce prices or slow price escalation.
3. What pricing models are predominant for biologic drugs like NDC 00121-1598?
Models include wholesale acquisition cost (WAC), average selling price (ASP), and value-based pricing, often adjusted via rebates, discounts, or outcomes-based agreements negotiated with payers.
4. How does market demand impact the future price of this medication?
Higher demand, driven by increasing disease prevalence and clinical adoption, supports sustained or modest price increases, barring significant competitive disruptions or policy shifts.
5. What strategies can manufacturers deploy to maximize revenue before patent expiration?
Strategies include innovation to expand indications, optimizing formulary placement, engaging in value-based contracts, and extending patent life via supplementary protective strategies.
References
- IQVIA Institute for Human Data Science. The Growing Value of Biologics. 2022.
- Evaluate Pharma. World Preview 2023. 2023.
- U.S. Food and Drug Administration (FDA). Biologics Price Competition and Innovation Act (BPCIA). 2010.
- Centers for Medicare & Medicaid Services (CMS). Drug Price Negotiation & Reimbursement Policies. 2023.
- Market research reports on biologics and biosimilars from Grand View Research and Frost & Sullivan.
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