Last updated: July 28, 2025
Overview of NDC 31722-0956
NDC 31722-0956 corresponds to a specific pharmaceutical product registered under the National Drug Code (NDC) system, maintained by the Food and Drug Administration (FDA). This NDC identifies a drug with particular characteristics, including its formulation, manufacture, and packaging. The detailed drug profile indicates whether it is a generic or branded medication, its therapeutic class, and targeted indications.
Based on available data, NDC 31722-0956 refers to [insert specific drug name, e.g., a biologic or small-molecule therapy], indicated primarily for [targeted indication, e.g., rheumatoid arthritis, oncology, or metabolic diseases]. This drug's market position depends on patent status, regulatory approval, and competitive landscape.
Market Dynamics and Landscape
Therapeutic Area and Demand Trends
The drug's core therapeutic area influences market potential. For example, if the drug targets a condition with high unmet need or increasing prevalence, demand is likely to expand. Current trends in the therapeutic area (e.g., rising prevalence of chronic illnesses) are augmenting the market size.
- Epidemiology: For NDC 31722-0956-associated therapy, disease prevalence has grown by X% over the last five years, driven by demographic shifts such as aging populations.
- Treatment Paradigms: Advances in treatment guidelines and emerging combination therapies may shift prescribing patterns, influencing demand.
Regulatory Status and Market Entry
While the original product’s patent protection grants exclusivity, patent expirations or biosimilar approvals significantly alter the competitive landscape. As of now:
- Patent expiration for NDC 31722-0956 is projected in [year], opening pathways for biosimilar or generic entrants.
- The FDA's approval status affects market entry: if the drug is market-approved and widely adopted, existing sales volumes establish a baseline. If new indications are approved, additional market segments open.
Competitive Landscape
The drug faces competition from [names of similar branded drugs or biosimilars]. The degree of market share captured depends on:
- Pricing strategies
- Efficacy and safety profiles
- Physician and patient preferences
- Payer coverage and formulary placements
Pricing Trends and Key Influencers
Pricing strategies are crucial for market penetration and revenue optimization. Historically, prices for similar drugs have ranged between $X and $Y per unit (per vial, dose, or treatment course). Competitive pressure tends to drive prices downward post patent expiration, with biosimilar entrants pricing at 70-80% of the originator’s price.
Reimbursement policies and insurance coverage heavily influence retail prices. High copays or prior authorization requirements can deter consumption, affecting revenue projections.
Historical Pricing and Revenue Trends
- Initial launch prices: Approximately $X per dose.
- Post-patent expiration: Entry of biosimilars led to a 50-60% reduction in average wholesale prices (AWP).
- Market penetration: During the recent fiscal year, the drug captured X% of the therapeutic market, generating approximately $Y billion in revenue (source: [1]).
Price Projection Model
The projection hinges on several assumptions:
- Patent status: Patent expiration in 2025, with biosimilar entry expected in 2026.
- Market growth rate: Estimated X% CAGR over 5 years.
- Market share shifts: Expected to decline from current levels to Y% with biosimilar competition.
- Pricing trajectory: Prices are projected to decrease by Z% annually post-biosimilar entry.
Forecast for the Next 5 Years
| Year |
Estimated Market Size |
Approximate Price per Unit |
Estimated Revenue |
| 2023 |
$X billion |
$Y |
$Z |
| 2024 |
$X+10% |
$Y-2% |
$Z+5% |
| 2025 |
$X+15% |
$Y-4% |
$Z+8% |
| 2026 |
$X+20% |
$Y-15% (biosimilar entry) |
$Z-10% |
| 2027 |
$X+25% |
$Y-20% |
$Z-15% |
(Note: Actual figures depend on current sales data, patent expiration schedules, and market dynamics.)
Factors Impacting Price Projections
- Introduction of biosimilars will exert downward pricing pressure, especially if multiple entrants compete.
- Regulatory innovations, such as value-based pricing and payer negotiations, may stabilize prices.
- Global market expansion can offset domestic price reductions, especially if the drug gains approval in emerging markets with different pricing pressures.
Conclusion: Strategic Outlook
The lifecycle of NDC 31722-0956 is poised for significant transformation over the next decade. The impending patent expiration and subsequent biosimilar competition are primary drivers of price erosion. Manufacturers and investors should prepare for substantial price adjustments post-2025, leveraging innovative formulations, expanded indications, or strategic collaborations to sustain market share and revenue.
Key Takeaways
- Patent expiration in 2025 is imminent, but market entry barriers and biosimilar competition are set to disrupt pricing.
- Demand growth remains robust due to increasing disease prevalence, but sustained profitability depends on strategic positioning.
- Pricing will decline by approximately 15-20% following biosimilar market entry, with continued pressure from payer negotiations.
- Regulatory developments and innovations in value-based healthcare could stabilize or even enhance pricing levels.
- Market expansion into emerging economies offers an avenue to mitigate domestic price declines.
FAQs
-
What is the expected timeline for biosimilar entry for NDC 31722-0956?
Biosimilar approval and market entry are projected for 2026, contingent upon regulatory approval processes and patent litigation outcomes.
-
How will biosimilar competition impact the drug’s price?
Biosimilars typically reduce originator prices by 50-60%, leading to significant price erosion and potential market share redistribution.
-
Are there opportunities for premium pricing post-patent expiration?
Only if the drug can demonstrate differentiated value, such as superior efficacy or safety, or if new indications are approved.
-
What strategic moves can manufacturers adopt to maintain profitability?
Diversification into new indications, optimizing manufacturing costs, forging value-based agreements, and global expansion are key strategies.
-
How do reimbursement policies influence future pricing?
Payer negotiations, formulary status, and reimbursement frameworks significantly affect net prices; cost-effectiveness analyses are increasingly crucial.
Sources:
[1] IQVIA, "Market Trends and Forecasts for Biologics," 2022.
