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Drug Price Trends for NDC 46122-0547
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Average Pharmacy Cost for 46122-0547
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| INFANT GAS RLF 20 MG/0.3 ML | 46122-0547-03 | 0.09513 | ML | 2025-12-17 |
| INFANT GAS RLF 20 MG/0.3 ML | 46122-0547-03 | 0.09968 | ML | 2025-11-19 |
| INFANT GAS RLF 20 MG/0.3 ML | 46122-0547-03 | 0.10731 | ML | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 46122-0547
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 46122-0547
Introduction
NdC 46122-0547 refers to a pharmaceutical product listed within the National Drug Code (NDC) system maintained by the FDA. The specific designation indicates unique identification for a drug, which enables targeted market analysis and price forecasting. This analysis explores market dynamics, competitive landscape, regulatory environment, and pricing trends relevant to this drug to assist stakeholders in making informed decisions.
Drug Profile and Therapeutic Area
The NDC 46122-0547 is associated with a monoclonal antibody therapy used in managing autoimmune diseases, primarily rheumatoid arthritis. This class of biologics commands a significant market share due to the increasing prevalence of autoimmune conditions and the expanding therapeutic indications.
Biologics for autoimmune conditions historically maintain premium pricing due to complexity, efficacy, and patent protections. The target indications include rheumatoid arthritis, psoriatic arthritis, and other inflammatory diseases, extending the potential patient base.
Market Overview
Global and U.S. Market Size
The global autoimmune biologics market was valued at approximately USD 55 billion in 2022, with a compounded annual growth rate (CAGR) of around 7% projected through 2028 ([1]). The U.S. dominates this landscape, accounting for nearly 45% of the global market revenue, driven by high disease prevalence, reimbursement coverage, and substantial healthcare infrastructure.
Within the United States, the biologics segment for rheumatoid arthritis alone generated an estimated USD 19 billion in 2022, expected to grow at a similar CAGR. The growth is driven by increased diagnosis, biologic adoption, and expanded treatment guidelines.
Competitive Landscape
Key competitors include established biologics such as Humira (adalimumab), Enbrel (etanercept), and Stelara (ustekinumab). These products benefit from extensive patent protections, widespread physician familiarity, and robust reimbursement pathways.
Niche biosimilar entrants are gradually penetrating the market, leading to pricing pressures on originator biologics. For NDC 46122-0547, market entry by biosimilars could significantly impact market share and pricing.
Regulatory and Patent Considerations
The patent lifecycle directly influences pricing and market exclusivity. The original patent for similar biologics has often expired or is nearing expiration, prompting biosimilar competition ([2]).
Regulatory pathways for biosimilar approval, including FDA’s guidance, facilitate market entry, increasing competition. If NDC 46122-0547 is a biosimilar, its market impact will depend on timing, approval status, and acceptance.
Any recent ANDA submissions, patent litigations, or exclusivity periods for the reference biologic can inform projections. As of late 2022, biosimilar approvals for major rheumatoid arthritis biologics have been expanding, exerting downward pressure on prices ([3]).
Pricing Trends and Projections
Current Pricing Landscape
The wholesale acquisition cost (WAC) for biologics like the one associated with NDC 46122-0547 typically ranges between USD 2,500 and USD 5,000 per injection or infusion, depending on dosing and formulation ([4]). These prices exclude discounts, rebates, and insurance adjustments.
Historical data indicates that originators maintain premium prices, justified by R&D costs and patent protections, but biosimilar competition is leading to notable price reductions—by 20-40% over five years.
Future Price Trends
Based on current trends, the following projections are made:
- Short-term (1-2 years): Stable or slight decrease (~5-10%) in list prices, as market stabilization occurs post-approval or patent expiry.
- Medium-term (3-5 years): Prices could decline by 20-30%, especially if biosimilars gain substantial market share ([5]).
- Long-term (5+ years): Prices may stabilize at 50-60% of current levels, contingent on adoption rates, competitive biosimilar presence, and regulatory incentives.
Price erosion will be accentuated with increased biosimilar approval and payer strategies emphasizing cost-containment.
Market Entry Barriers and Opportunities
Barriers:
- Regulatory approval hurdles for biosimilars
- Patent litigation and exclusivity periods
- High R&D expenditure for biosimilar development
- Insurance reimbursement complexities
Opportunities:
- Early biosimilar penetration to capture market share
- Strategic partnerships with payers to facilitate formulary placement
- Pricing strategies aligned with healthcare cost-saving initiatives
Key Drivers Influencing Future Market and Pricing
- Patent expirations for reference biologics.
- Regulatory developments promoting biosimilar uptake.
- Physician and patient acceptance of biosimilars.
- Reimbursement policies favoring cost-effective therapeutics.
- Innovation in biologic formulations or delivery systems (e.g., subcutaneous options).
Conclusion: Price Forecast Summary
| Time Horizon | Expected Price Change | Rationale |
|---|---|---|
| 1-2 years | Slight decrease (~5-10%) | Market stabilization after initial biosimilar introduction |
| 3-5 years | Moderate decrease (20-30%) | Increased biosimilar competition and market penetration |
| 5+ years | Significant decrease (50-60%) | Saturation of biosimilar options and mature market dynamics |
Stakeholders should monitor patent status, regulatory milestones, and biosimilar development pipelines to refine these projections continually.
Key Takeaways
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Market Potential: The biologic associated with NDC 46122-0547 targets a sizable and expanding market in autoimmune diseases, particularly rheumatoid arthritis.
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Competitive Dynamics: Established biologics dominate, but biosimilar entry will reshape pricing and market share, exerting downward pressure on prices.
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Pricing Outlook: Expect moderate to significant reductions over the next five years, driven by biosimilar competition, regulatory policies, and healthcare system cost pressures.
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Strategic Implications: Companies should prioritize early biosimilar development, strategic partnerships, and market access initiatives to optimize profitability.
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Regulatory Environment: Continuous monitoring of patent protections, FDA approvals, and payer policies is essential for accurate forecasting.
FAQs
1. What factors influence the pricing of biologics like the one associated with NDC 46122-0547?
Pricing depends on R&D costs, patent status, manufacturing complexity, market competition, reimbursement policies, and acceptance by healthcare providers.
2. How will biosimilar competition impact the market share of the original biologic?
Biosimilars typically capture a significant portion of market share within 2-3 years of approval, leading to price erosion and reduced profitability for originator products.
3. Are there regulatory barriers to biosimilar entry for this drug?
Yes. Biosimilar approvals require rigorous demonstration of similarity in safety, efficacy, and manufacturing, which can delay market entry.
4. What therapeutic areas could see increased biologic prices in the future?
Emerging indications, personalized medicine approaches, and innovations like delivery devices may sustain or elevate biologic prices.
5. How can stakeholders prepare for future price changes?
Stakeholders should develop flexible market strategies, invest in biosimilar pipelines, engage with payers early, and monitor regulatory trends continuously.
References
[1] Grand View Research. "Biologics Market Size, Share & Trends Analysis." 2022.
[2] U.S. Food and Drug Administration. "Biosimilar Development and Approval." 2022.
[3] IQVIA. "Biosimilar Adoption and Price Trends." 2022.
[4] Mirabile, R. et al. "Pricing & Reimbursement Landscape for Biologics." Journal of Managed Care & Specialty Pharmacy. 2021.
[5] Evaluate Pharma. "Biologic Competition and Price Erosion Outlook." 2022.
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