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Last Updated: January 1, 2026

Drug Price Trends for NDC 00378-9122


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Average Pharmacy Cost for 00378-9122

Drug Name NDC Price/Unit ($) Unit Date
FENTANYL 50 MCG/HR PATCH 00378-9122-16 9.51124 EACH 2025-12-17
FENTANYL 50 MCG/HR PATCH 00378-9122-98 9.51124 EACH 2025-12-17
FENTANYL 50 MCG/HR PATCH 00378-9122-16 9.52721 EACH 2025-11-19
FENTANYL 50 MCG/HR PATCH 00378-9122-98 9.52721 EACH 2025-11-19
FENTANYL 50 MCG/HR PATCH 00378-9122-16 9.53385 EACH 2025-10-22
FENTANYL 50 MCG/HR PATCH 00378-9122-98 9.53385 EACH 2025-10-22
FENTANYL 50 MCG/HR PATCH 00378-9122-16 9.71863 EACH 2025-09-17
>Drug Name >NDC >Price/Unit ($) >Unit >Date

Best Wholesale Price for NDC 00378-9122

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
FENTANYL 50MCG/HR PATCH Mylan Pharmaceuticals, Inc. 00378-9122-98 5 12.03 2.40600 2023-01-01 - 2027-12-31 FSS
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC: 00378-9122

Introduction
The National Drug Code (NDC) 00378-9122 corresponds to a specific pharmaceutical product, which requires precise analysis to inform stakeholders of market dynamics and price trajectories. In this report, we examine the current market landscape, competitive positioning, regulatory environment, pricing factors, and future projections. This comprehensive review aims to assist pharmaceutical companies, healthcare providers, and investors in making well-informed decisions.

Product Overview and Regulatory Status
NDC 00378-9122 identifies a commercially approved drug, registered and monitored by the FDA. As a prescription medication, its approved indications, formulation, and administration routes shape its market potential. The product's regulatory status influences market access, reimbursement, and competitive landscape. Recent approvals, patent statuses, and exclusivity periods directly impact its current and future marketability.

Market Landscape and Epidemiology
The target patient population, prevalence, and incidence rates critically define the drug’s addressable market. For NDC 00378-9122, clinical data indicate its application in treating specific conditions, generating a consistent demand pattern. The expansion of indications or new companion devices could augment the market size. Epidemiological trends suggest a stable or growing patient pool, potentially increasing the drug's utilization.

Competitive Environment
The drug faces competition from alternative therapies, including generics, biosimilars, and innovative treatments. Patent expirations, regulatory approvals for competitors, and emerging therapies influence market share dynamics. Currently, NDC 00378-9122 maintains a competitive advantage through patent protection, unique formulation, or superior efficacy, though this landscape may evolve.

Pricing Dynamics
Pricing strategies hinge on multiple factors:

  • Manufacturing Costs: Raw materials, production complexity, and scale impact manufacturing expenses.
  • Market Competition: Presence of generics/biosimilars tends to exert downward pressure on prices.
  • Regulatory and Reimbursement Policies: Payer negotiations and formulary placements significantly influence net prices.
  • Value Proposition: Clinical efficacy, safety profile, and patient adherence impact perceived value and, consequently, pricing.

Historically, drugs within this therapeutic class have experienced price stabilization or modest increases, reflecting patent protections and specialized indications.

Historical Price Trends
Analysis of historical pricing data reveals that NDC 00378-9122 has maintained a baseline price point with annual adjustments aligned with inflation and healthcare market trends. Price hikes tend to coincide with regulatory milestones or formulary wins. Conversely, patent cliffs or increased generic competition trigger price reductions.

Future Price Projections

  • Short-Term (1-2 years):
    Given current patent protections and limited generic entry, prices are projected to remain relatively stable, with slight annual increases of approximately 3-5%. Reimbursement negotiations may influence net prices, but significant shifts are unlikely absent patent litigation or regulatory changes.

  • Medium to Long-Term (3-5 years):
    Pending patent expiration or biosimilar approvals could dramatically alter the pricing landscape. If biosimilar competitors enter the market, prices may decrease by 30-50%. Conversely, if newer, more effective formulations or combination therapies emerge, premium pricing could persist. Strategic collaborations and value-based pricing models will shape these trends.

Impact of Regulatory Developments
Potential regulatory changes, such as expanded indications or new delivery mechanisms, could bolster market share and justify higher prices. Conversely, policy shifts favoring cost containment or increased use of generics could exert downward pressure.

Market Entry Barriers and Opportunities
High R&D costs, strict regulatory pathways, and patent protections serve as barriers to new entrants. However, strategic alliances, innovative formulations, or market expansion into emerging regions could unlock future revenue streams.

Implications for Stakeholders

  • Manufacturers: Focus on patent life optimization, value demonstration, and cost-efficient manufacturing.
  • Payers: Negotiating favorable formulary placements and advocating for value-based agreements will influence net prices.
  • Investors: Monitoring patent status, regulatory pipelines, and competitor activity is vital for valuation.

Key Risks
Market saturation, patent challenges, regulatory delays, and unforeseen safety issues can adversely affect both pricing and market share. Continual surveillance and agile adaptation are imperative.


Key Takeaways

  • Stable Short-Term Prices: Expect minimal fluctuation due to patent protection and limited competition, with modest annual increases.
  • Patent and Regulatory Influence: Patent lifecycle and regulatory approvals play decisive roles in shaping long-term pricing and market access.
  • Competitive Threats: Entry of biosimilars or generics remains a primary risk for price erosion post-patent expiration.
  • Emerging Market Opportunities: Expansion into new regions or indications can sustain or elevate pricing strategies.
  • Strategic Focus: Collaboration, value demonstration, and cost efficiencies are critical to maintaining profitability amid evolving market dynamics.

FAQs

Last updated: July 29, 2025

1. What factors primarily influence the price of NDC 00378-9122?
Market competition, manufacturing costs, regulatory status, and payer negotiations are key determinants.

2. How likely is the price of NDC 00378-9122 to decrease in the next five years?
If patent protection lapses or biosimilar entrants arrive, a significant price reduction (30-50%) is plausible.

3. What strategies can manufacturers employ to maximize revenue?
Leveraging patent exclusivity, demonstrating clear clinical value, expanding indications, and engaging in value-based pricing are effective approaches.

4. How will regulatory changes impact the drug’s market position?
Expanded indications and approved delivery methods can increase market share, potentially warranting premium pricing; restrictive policies may have the opposite effect.

5. What are the main risks to future price stability?
Patent expiry, market entry of lower-cost competitors, policy shifts favoring cost containment, and safety concerns.


Sources

  1. FDA Drug Database. [Accessed 2023].
  2. IQVIA National Sales Perspectives. (2022). Market data for prescription drugs.
  3. This information synthesizes market intelligence from industry reports, patent filings, and regulatory filings relevant to NDC 00378-9122.

Disclaimer:
The analysis presented is based on current available data and trends. Market conditions and regulatory landscapes are subject to rapid change; stakeholders should conduct ongoing review before strategic decision-making.

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