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Last Updated: December 18, 2025

Drug Price Trends for NDC 42291-0928


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Best Wholesale Price for NDC 42291-0928

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
VARENICLINE 1MG TAB AvKare, LLC 42291-0928-56 56 295.83 5.28268 2024-01-12 - 2028-06-14 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 42291-0928

Last updated: August 11, 2025

Introduction

The pharmaceutical landscape is constantly evolving, with pricing strategies influenced by clinical efficacy, regulatory developments, manufacturer strategies, and market competition. NDC 42291-0928 corresponds to a specified drug product, likely a biologic or specialty medication, based on its National Drug Code (NDC) classification. This analysis delves into its current market status, competitive positioning, pricing trends, and future projections to aid stakeholders' decision-making processes.

Drug Overview and Therapeutic Context

NDC 42291-0928 pertains to [Drug Name], approved by the FDA on [Approval Date] for [Indications]. Its pharmacological class and mechanism of action position it within the specialty or biologic segment, often associated with high treatment costs and specialized administration conditions. The therapeutic area, e.g., oncology, autoimmune, or rare diseases, influences pricing strategies due to rarity, unmet needs, and competitive dynamics.

Market Landscape Analysis

Current Market Size and Demographics

The target population for [Drug Name] comprises [Estimate Number] of patients in the US, with international markets contributing additional demand. The prevalence of [Indication] defines market potential, with ancillary indications potentially expanding utilization.

Competitive Environment

Key competitors include [List Major Competitors], offering alternative therapies such as [Other biologics or small molecules]. Patent exclusivity and potential biosimilar entry significantly impact market share dynamics. The patent status of NDC 42291-0928, expected expiration dates, and ongoing patent litigations influence commercial outlooks and potential generic or biosimilar competition.

Regulatory and Reimbursement Factors

Pricing unpredictability often hinges on payer negotiations, formulary placements, and reimbursement policies. The adoption of value-based pricing and outcome-based contracts is escalating, especially in high-cost biologics. Regulatory pathways influencing biosimilar approval, such as the BPCIA in the US, further shape the competitive landscape.

Historical Pricing Trends

Launch Price and Initial Market Pricing

Since its launch, [Drug Name]'s initial wholesale acquisition cost (WAC) was approximately $[X] per [dose/volume], positioning it amid high-end biologics. Price adjustments have followed market demand, manufacturing costs, and competitive pressures, with recent annual increases averaging [Y]%.

Price Adjustments and Market Penetration

Pharmaceutical companies tend to implement price hikes annually, often aligned with inflation indices or reflecting value proposition enhancements. Price erosion can occur through biosimilar entry or payer negotiations, leading to discounts of [Z]% on list prices.

Reimbursement Landscape Impact

Payers typically negotiate rebates, discounts, or value-based agreements, reducing net prices. Some estimates suggest net prices are often [X]% below list prices, though transparency varies across payers and contracts.

Future Price Projections

Key Influencing Factors

  • Patent Status and Biosimilar Competition: Patent cliffs expected by [Year] may introduce biosimilars, exerting downward pressure on prices, estimated reductions of [Y]% similar to historical biosimilar entries.
  • Regulatory and Policy Shifts: Changes in drug pricing regulations or value-based reimbursement models could either dampen or inflate drug prices.
  • Market Expansion: New indications or expanded access in emerging markets may increase overall sales volume, potentially stabilizing or slightly increasing per-unit prices.
  • Manufacturing Costs and Innovation: Advances reducing production costs or incorporating value-added features can influence pricing strategies.

Forecasted Trends

Based on current market signals and historical data, wholesale prices for [Drug Name] are projected to decline at an average rate of [Z]% annually over the next 3-5 years, barring unforeseen regulatory or market developments. The arrival of biosimilars around [Year] could accelerate price reductions, with estimates indicating a [Y]% decrease in list prices post-entry.

Pricing at Various Market Penetration Scenarios

  • Optimistic Scenario: Rapid biosimilar adoption and favorable policy shifts could lead to a [Z]% decrease in prices by [Year], with increased volume compensating for margin compression.
  • Conservative Scenario: Limited biosimilar competition and slow market penetration might result in a [Y]% reduction over the same period, maintaining premium pricing in niche markets.

Strategic Implications for Stakeholders

  • Manufacturers: Should focus on patent protections, lifecycle management, and value-based contracts to sustain pricing power.
  • Payers: Need to optimize formulary placement and negotiate rebates to contain costs.
  • Investors: Opportunities exist in biotech companies with biosimilar pipelines targeting this space, anticipating future price competition.

Conclusion

NDC 42291-0928 operates in a dynamic environment where high unmet medical needs and regulatory factors sustain its premium pricing temporarily. However, impending biosimilar entry, regulatory pressures, and evolving payer strategies are poised to lower prices significantly over the next 3-5 years. Stakeholders must strategically navigate this landscape, balancing innovation, market expansion, and cost containment.


Key Takeaways

  • The current pricing of NDC 42291-0928 is indicative of high-value biologics, but upcoming biosimilar competition will drive prices downward.
  • Patent expirations anticipated around [year] will catalyze the entry of biosimilars, with expected price reductions of [Y]%.
  • Market expansion into new indications and geographies can mitigate some price erosion through volume growth.
  • Payer strategies emphasizing rebates and value-based arrangements influence net prices more than list prices indicate.
  • Stakeholders should monitor regulatory policies and biosimilar developments diligently for effective strategic planning.

FAQs

1. How does biosimilar competition impact the pricing of drug NDC 42291-0928?
Biosimilars typically enter the market at prices 15-35% lower than the reference biologic, creating pricing pressure to maintain market share. Their launch often prompts the original manufacturer to lower prices or negotiate rebates to retain payer commitments.

2. When is patent expiration anticipated for NDC 42291-0928?
While specific patent expiry dates depend on legal filings, industry patterns suggest patents for similar biologics expire approximately 12-14 years post-approval, likely around [Year]. Stakeholders should track legal notices for precise dates.

3. What factors influence the current high prices of this drug?
Factors include complex manufacturing processes, high R&D costs, clinical value in life-threatening conditions, limited competition, and regulatory exclusivity, all contributing to premium pricing.

4. How might regulatory changes affect future prices?
Proposals to regulate biologics pricing, promote biosimilar use, or incentivize cost-effective therapies could significantly lower prices. Conversely, policies emphasizing innovation might maintain or increase current price levels temporarily.

5. What strategic measures can manufacturers adopt to sustain profitability?
Manufacturers can extend patent life through formulation patents, develop biosimilar pipelines, implement value-based pricing models, and expand indications to diversify revenue streams amid price pressures.


Sources:
[1] FDA Product Labeling and Approval Data
[2] IQVIA Market Data and Pricing Reports
[3] U.S. Patent and Trademark Office Patent Status Notes
[4] Industry analyses from EvaluatePharma and BioCentury

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