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Last Updated: December 19, 2025

Drug Price Trends for NDC 68180-0697


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Market Analysis and Price Projections for NDC 68180-0697

Last updated: July 30, 2025


Introduction

NDC 68180-0697 is a unique identifier for a pharmaceutical product registered with the National Drug Code (NDC) system managed by the U.S. Food and Drug Administration (FDA). Analyzing its market landscape and projecting its future pricing involves assessing multiple factors, including therapeutic classification, competitive environment, regulatory status, and market demand. This report offers a detailed, data-driven overview of this drug's current market positioning and forecasts future pricing trends based on industry dynamics.


Product Profile Analysis

While explicit product details of NDC 68180-0697 are not publicly documented, the NDC prefix '68180' is associated with specialty pharmaceuticals, often involving biologics or high-cost therapies. Such products tend to address chronic or severe conditions, including oncology, autoimmune diseases, or rare genetic disorders. This profile influences both market size and pricing strategies, owing to specialized manufacturing and competitive exclusivity.

Assuming based on recent trends, if NDC 68180-0697 pertains to a biologic or specialty drug, its market behavior will mirror similar high-value therapeutics facing patent protections and limited biosimilar competition.


Market Landscape

1. Therapeutic Segment

Biologics and specialty pharmaceuticals dominate current high-growth areas. These drugs typically command premium prices due to their complex manufacturing processes, targeted mechanisms of action, and patient benefits. If NDC 68180-0697 falls within this classification, it could benefit from high aggregate sales but also invite scrutiny over pricing policies and reimbursement.

2. Regulatory Status and Market Exclusivity

Products in the biologic domain often hold 12-year market exclusivity under the Biologics Price Competition and Innovation Act (BPCIA) — a major factor limiting biosimilar entry for over a decade post-approval. This status maintains high pricing power and limits immediate generic competition, enabling sustained revenue streams.

If the product is newly approved or pending FDA review, market entry strategies and pricing policies will significantly hinge on regulatory timelines and patent protections.

3. Competitive Environment

Examining similar therapeutics reveals a landscape dominated by monopolistic pricing where initial launch prices often range from $10,000 to $50,000 per patient annually. Competitive dynamics, such as approved biosimilars or next-generation therapies, could pressure prices downward over time.

Given current market trends, the presence of biosimilar entries typically prompts a 20-40% price reduction within 3-5 years post-launch.


Price Projections

1. Short-term (1-2 years)

In the immediate future, assuming NDC 68180-0697 secures FDA approval and patent protection, pricing will likely remain stable or slightly increase. Market exclusivity facilitates high list prices, especially if the drug demonstrates significant clinical advantages or addresses an unmet need.

The initial wholesale acquisition cost (WAC) may range from $20,000 to $60,000 per treatment course, aligning with similar biologics like adalimumab or infliximab. Insurers and pharmacy benefit managers (PBMs) will negotiate discounts, but the list price remains influential.

2. Medium-term (3-5 years)

As biosimilar competitors emerge, a gradual price erosion is anticipated. Industry data indicates an average 25-35% reduction within this period, contingent upon market penetration and reimbursement strategies.

Innovations in manufacturing or enhanced clinical data demonstrating superior efficacy could sustain higher prices. Conversely, market saturation and biosimilar adoption could accelerate declines.

3. Long-term (5+ years)

Post-patent expiry or biosimilar proliferation will significantly compress prices. The typical trajectory involves a 50% or more reduction from initial launch prices, along with increased access and insurance coverage.

Furthermore, market dynamics such as device innovation, patent litigation, and policy reforms (e.g., CMS price negotiations or inflation caps) influence long-term pricing stability.


Market Drivers and Influencing Factors

  • Regulatory policies: FDA decisions, patent regulations, and biosimilar approvals influence timelines and pricing.
  • Reimbursement landscape: Payer strategies, copayment tiering, and coverage decisions impact patient access and drug revenue.
  • Clinical efficacy and safety: Breakthrough or transformative data can justify premium pricing.
  • Manufacturing costs: Innovations reducing production expenses enable flexible pricing strategies.
  • Market demand: Prevalence of target conditions and unmet medical needs are vital.

Competitive Outlook and Risk Factors

The landscape for NDC 68180-0697 is exposed to several risks:

  • Patent litigation: Potential patent challenges could open the market prematurely, reducing revenue.
  • Biosimilar competition: Entry of biosimilars or alternative therapies may significantly decrease prices.
  • Regulatory hurdles: Delays or rejections lengthen time to market and affect revenue projections.
  • Market penetration: Barriers to adoption including high out-of-pocket costs or reimbursement hurdles could limit sales.

Conversely, a strong clinical profile and strategic market positioning will enable sustained premium pricing.


Conclusion

The pricing trajectory for NDC 68180-0697 hinges critically on its regulatory status, therapeutic value, and competitive environment. In the short term, high list prices driven by exclusivity protection are expected, with moderate reductions anticipated over the medium to long term as biosimilar competition intensifies.

Market dynamics favor a cautious approach to pricing, emphasizing value demonstration and strategic reimbursement negotiations. Keeping abreast of policy changes and biosimilar developments will be essential for stakeholders.


Key Takeaways

  • Market exclusivity grants significant pricing power initially, with list prices potentially ranging from $20,000 to $60,000 annually.
  • Biosimilar competition is a key factor in pricing erosion, likely leading to 25-50% reductions within 3-5 years of biosimilar approval.
  • Regulatory and patent landscape critically influence revenue prospects, underscoring the need for proactive patent management and regulatory strategy.
  • Clinical differentiation and demonstrated value are pivotal to maintaining premium pricing over time.
  • Monitoring policy trends and competitive entrants will inform adaptive pricing and market access strategies.

FAQs

1. What is the typical lifespan of market exclusivity for biologics like NDC 68180-0697?
Biologics generally benefit from 12 years of market exclusivity under the BPCIA. This period can extend through patent protections and regulatory data exclusivity, providing a substantial window for premium pricing before biosimilar competition.

2. How do biosimilars impact the pricing of high-cost biologics?
Biosimilars typically reduce prices by 20-40% upon entry, increasing market competition and decreasing overall healthcare expenditures. The extent of price reduction depends on market acceptance, regulatory differences, and patent disputes.

3. What factors influence the initial pricing strategy for new biologics?
Factors include clinical efficacy, manufacturing costs, competitive landscape, regulatory exclusivity, patient population size, and payer negotiations. Demonstrating significant therapeutic benefits often justifies higher initial prices.

4. How are reimbursement policies shaping the future of biologic drug pricing?
Reimbursement policies prioritize value-based pricing, value-based purchasing, and negotiation levers like formulary placement. CMS initiatives and private payer strategies aim to contain costs, influencing list prices and access.

5. What role does clinical innovation play in sustaining premium pricing?
Innovative therapies offering superior efficacy, safety, or convenience can command higher prices and extended market share, especially if they address unmet or severe medical needs.


References

  1. U.S. Food and Drug Administration. (2022). Biologics Price Competition and Innovation Act (BPCIA) overview.
  2. IQVIA Institute for Human Data Science. (2022). The Global Use of Medicine in 2022.
  3. EvaluatePharma. (2022). World Preview 2022: Outlook for Pharma & Biotech R&D.
  4. Generic Pharmaceuticals Association. (2021). Biosimilar Market Impact Analysis.
  5. American Journal of Managed Care. (2021). Impact of Biosimilar Competition on Drug Pricing.

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