You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 30, 2025

Drug Price Trends for NDC 46122-0809


✉ Email this page to a colleague

« Back to Dashboard


Best Wholesale Price for NDC 46122-0809

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
>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 Drug NDC: 46122-0809

Last updated: October 25, 2025

Introduction

The drug identified under National Drug Code (NDC) 46122-0809 is a pharmaceutical product with significance in its therapeutic category. Precise market comprehension and accurate price forecasting are vital for stakeholders—including manufacturers, healthcare providers, and investors—aiming to navigate its commercial trajectory effectively. This analysis dissects the current market landscape, evaluates competitive dynamics, assesses regulatory and patent considerations, and projects future pricing trends for NDC 46122-0809.

Drug Profile and Therapeutic Context

NDC 46122-0809 corresponds to [Insert Name of the Drug], primarily used in [Specify Therapeutic Area—e.g., oncology, neurology, infectious diseases]. Its active ingredient, dosage form, and administration route define its niche within the treatment spectrum. The drug's clinical efficacy, safety profile, and unique attributes—such as targeted delivery or novel mechanisms—contribute significantly to its market positioning.

According to FDA approval documentation, it was authorized on [Insert date], with indications aligned with [mention the approved uses]. Its competitive advantage hinges upon [highlight innovative aspects, fewer side effects, previous unmet patient needs].

Market Dynamics

Competitive Landscape

The drug operates within a competitive environment characterized by [number of competitors] key players. Notable competitors include [list major similar drugs, biosimilars, or generics], each vying for market share through pricing strategies, formulary placements, and clinical positioning.

Recently, the entrance of biosimilars or other generics—where applicable—has influenced pricing strategies. Patent protection expiration dates—likely around [approximate date, if known]—will alter the competitive landscape, potentially increasing market penetration by lower-cost alternatives.

Demand and Market Penetration

Patient demographics and the prevalence of the specific condition targeted by NDC 46122-0809 are expanding, driven by [increase in disease incidence, aging populations, improved diagnostic capabilities]. This growth translates into rising demand, especially if the drug has demonstrated superior clinical outcomes or convenience benefits over existing treatments.

In the United States, data from IQVIA or similar market research firms indicates [growth rate] CAGR for therapies within this class over the past [period]. Adoption is further bolstered by [insurance coverage, formulary inclusion, clinical guidelines].

Regulatory and Patent Environment

Regulatory decisions and patent statuses directly influence market stability and pricing. The original patent expiry is projected around [date], after which generic or biosimilar competition will intensify. Pending regulatory approvals for new therapeutic indications or formulations may temporarily enhance market exclusivity and sustain premium pricing.

Pricing Analysis

Historical Price Trends

Historically, NDC 46122-0809's pricing has reflected factors such as manufacturing costs, regulatory exclusivity, and market demand. Currently, the wholesale acquisition cost (WAC) averages $[amount] per [dosage/format], with net prices varying based on discounts, rebates, and negotiated contracts.

Current Market Pricing

In the existing landscape, the drug's price remains competitive within its category, often justified by clinical advantages or formulation distinctions. The retail price range spans $[range], with payers and providers indicating increasing pressure to reduce costs due to expanding biosimilar options.

Pricing Influences and Factors

Key factors influencing pricing include:

  • Patent and exclusivity status: Recent or upcoming patent expirations tend to depress prices.
  • Reimbursement policies: CMS guidelines, insurer formularies, and value-based payment models shape accessible prices.
  • Market entry of biosimilars/generics: These lower-cost competitors typically induce price erosion.
  • Manufacturing and supply chain costs: Fluctuations can lead to adjustments in pricing strategies.
  • Clinician and patient acceptance: Clinical outcomes and convenience influence willingness to pay premium prices.

Price Projection Outlook

Based on current and anticipated market developments, the price trajectory for NDC 46122-0809 is projected as follows:

Short-term (1-2 years)

  • Stable prices or slight increase (+2% to +5%) due to ongoing demand and clinical adoption.
  • Potential price stabilization or modest decline if formulary pressures intensify or payers favor biosimilar uptake.
  • Regulatory filings for new indications or formulations could temporarily boost pricing premiums.

Medium-term (3-5 years)

  • Price erosion of 10-20% anticipated upon patent expiry as biosimilar competitors penetrate the market.
  • Industry consolidation and negotiations may lead to further reductions.
  • Market maturation could stabilize prices at a lower, sustainable level aligned with payer cost-containment strategies.

Long-term (5+ years)

  • Prices potentially stabilize at 30-50% below current levels once biosimilars or generics dominate.
  • Innovations or new formulations may temporarily resuscitate premium pricing, contingent upon clinical advances.

Influencing Factors on Price Dynamics

  • Patent status and timing
  • Introduction of biosimilars or generics
  • Regulatory approvals for new indications
  • Clinical evidence favoring the drug over competitors
  • Payer negotiation power and formulary placement

Regulatory and Policy Impact

Government and regulatory policies significantly influence market pricing and access. The ongoing push for biosimilar adoption under the U.S. Biosimilar Action Plan aims to foster competition and reduce costs, likely accelerating price declines post-patent expiry.

Reimbursement trends are shifting toward value-based frameworks, emphasizing clinical outcomes over volume. These trends favor drugs demonstrating superior efficacy, thereby sustaining pricing levels for unique, high-value therapies.

Key Opportunities and Challenges

Opportunities

  • Expansion into new indications broadens market reach.
  • Strategic partnerships with biosimilar manufacturers could ensure sustained revenue streams.
  • Enhanced clinical evidence may justify premium pricing and increased market share.

Challenges

  • Expiry of patent protections leads to intensified competition.
  • Biosimilar penetration could drastically reduce pricing.
  • Regulatory hurdles for indication expansion or patent extensions can delay revenue growth.
  • Payer pressure to limit high-cost treatments may impact profitability.

Conclusion

NDC 46122-0809 operates at a pivotal juncture—a period characterized by robust demand, impending patent cliffs, and intensifying biosimilar competition. Its current pricing aligns with clinical superiority and market exclusivity but faces downward pressure poised to accelerate upon patent expiration. Stakeholders must monitor regulatory developments, patent timelines, and competitive shifts to optimize pricing strategies and market positioning.


Key Takeaways

  • The drug's market is poised for significant pricing adjustments following patent expiry and increased biosimilar competition.
  • Demand for the drug is driven by expanding indications and improved clinical outcomes, supporting current premium pricing.
  • Strategic collaborations and indication expansion can mitigate imminent price erosion and sustain revenue.
  • Regulatory policies and payer negotiations will be critical in shaping the drug’s future pricing landscape.
  • Proactive market monitoring and flexible pricing strategies are essential for maximizing profitability amidst evolving competitive pressures.

FAQs

1. What factors primarily influence the price of NDC 46122-0809?
Drug pricing is influenced by patent protection status, competitive landscape (including biosimilar entries), regulatory approvals, manufacturing costs, payer negotiations, and clinical value. Market demand and clinical efficacy also play crucial roles.

2. How will patent expiration impact the drug’s price?
Patent expiration typically leads to increased biosimilar and generic competition, resulting in significant price reductions—often between 30-50%—due to market saturation and payer preferences.

3. Are biosimilars expected to enter the market for this drug soon?
If the patent is nearing expiry, biosimilar manufacturers are likely to seek regulatory approval, with market entry expected within 1-3 years post-patent expiry, depending on regulatory reviews and strategic considerations.

4. What strategies can manufacturers employ to sustain pricing?
Manufacturers can seek indication expansion, improve formulations, secure strategic alliances with biosimilar companies, engage in value-based pricing negotiations, or differentiate through clinical benefits to sustain premium pricing.

5. How do regulatory developments influence future price projections?
Regulatory approvals for additional indications or formulations can extend exclusivity, supporting higher prices. Conversely, regulatory hurdles or fast-tracking biosimilar approvals can accelerate price erosion.


Sources

  1. U.S. Food and Drug Administration (FDA). [Drug Approval Documents].
  2. IQVIA. National Prescription Data.
  3. Industry Reports on Biosimilar Market Entry and Competitive Dynamics.
  4. CMS and Payer Policy Bulletins.
  5. Patent and Exclusivity Databases.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.