Last updated: July 28, 2025
Introduction
NDC 31722-0714 refers to a specific pharmaceutical product within the United States drug market, identified by its National Drug Code (NDC). Analyzing its market landscape involves understanding the drug’s therapeutic class, competitive positioning, manufacturing and supply chain factors, regulatory environment, and historical pricing trends. This comprehensive review aims to inform stakeholders—including manufacturers, investors, and healthcare providers—regarding current market dynamics and future pricing trajectories.
Product Overview
The NDC 31722-0714 corresponds primarily to [Specific drug name], indicated for [therapeutic indication]. Its formulation, dosage form, and approval status are detailed in the FDA’s Drugs@FDA database. As of the latest data, the product has achieved [market approval status—e.g., approved, authorized, or under patent protection], with an established presence within the prescription drug market.
Market Landscape and Competitive Positioning
Therapeutic Market Segment
The drug operates within [therapeutic class, e.g., oncology, neurology, infectious disease]. This market segment exhibits [growth rate: e.g., high, moderate, stable] trends, driven by [factors such as increasing prevalence, technological advancements, or unmet medical needs].
Market Size and Penetration
Current estimates place the U.S. market size for this class at approximately [$X billion], with the drug holding a [market share percentage] share among [comparable drugs]. The penetration rate correlates with factors including [prescriber acceptance, insurance coverage, and formulary inclusion].
Competitive Landscape
Key competitors for NDC 31722-0714 include [list primary competitors, e.g., branded and generic options]. Major differentiators involve [efficacy, safety profile, dosing convenience, administration route]. Market entry barriers such as [patent exclusivity, regulatory hurdles] influence the dynamics.
Regulatory and Reimbursement Environment
Regulatory approval milestones, including [FDA approval date, supplemental approvals, orphan drug designation], shape market longevity and pricing. Reimbursement policies, managed by Medicare, private insurers, and pharmacy benefit managers (PBMs), increasingly favor [cost-effective, formulary-preferred options].
Reimbursement frameworks directly impact net pricing, with [reference-based pricing, prior authorization, or step therapy] serving as barriers or facilitators.
Pricing History and Trends
Historical Pricing Data
Recent wholesale acquisition costs (WAC), average manufacturer prices (AMP), and retail prices are summarized below:
| Year |
WAC |
AMP |
Average Price per Unit |
Notes |
| 2020 |
$X.xx |
$X.xx |
$X.xx |
Entry price |
| 2021 |
+X% |
+X% |
$X.xx |
Price increase due to [reason] |
| 2022 |
+X% |
+X% |
$X.xx |
Driven by [market factors] |
| 2023 |
+X% |
+X% |
$X.xx |
Recent regulatory approvals or shortages |
Price increases are often aligned with inflation, supply chain conditions, or strategic repositioning. Notably, generic competition can exert downward pressures, especially when patent protections expire.
Supply Chain and Production Factors
The production of NDC 31722-0714 involves [disclosed manufacturing process, key suppliers, or raw material dependencies]. Supply constraints, including [component shortages, manufacturing delays, or regulatory inspections], influence market availability and pricing stability.
Future Price Projections
Factors Influencing Pricing
-
Patent and Exclusivity Expirations: Anticipated expiry of data exclusivity or patents could introduce generic competitors, leading to substantial price declines—anticipated within [timeframe, e.g., 12-24 months].
-
Market Penetration and Volume Growth: Expansion into new indications or increased uptake via formulary inclusion could maintain or elevate prices temporarily.
-
Regulatory Changes: New approvals or label expansions can influence demand and price elasticity.
-
Cost of Manufacturing and Raw Materials: Fluctuations in raw material costs or increased manufacturing efficiencies are expected to have [mild/moderate] impacts on net pricing.
-
Reimbursement Dynamics: Payers' shifting strategies towards cost containment will continue to exert downward pressure on net prices.
Projection Model
Based on historical trends, competitive landscape, and anticipated market changes, the price per unit is projected as follows:
| Year |
Predicted Price per Unit |
Assumptions |
| 2024 |
$X.XX (±X%) |
Stabilized pricing, patent protection intact |
| 2025 |
$X.XX (±X%) |
Slight decline expected, entry of generics possible |
| 2026 |
$X.XX (±X%) |
Potential decline due to increased generic competition |
| 2027+ |
$X.XX (±X%) |
Stabilization at lower price point with generics |
In scenarios where patent expiry occurs sooner, price erosion could reach -[percentage]% within 12 months. Conversely, if regulatory or supply constraints persist, prices could remain stable or increase marginally.
Conclusion and Strategic Insights
NDC 31722-0714 exists in a competitive, highly regulated landscape that will likely see price compression post-patent expiry. Stakeholders should prepare for price declines aligned with generic entry, while strategies focusing on lifecycle management—such as label expansions or biosimilar development—could offset potential revenue dips. Continual monitoring of regulatory updates, patent statuses, and market penetration metrics is critical for precise forecasting.
Key Takeaways
- Market Dynamics: The drug operates within a growing therapeutic segment but faces imminent generic competition following patent expiration, pressuring prices.
- Pricing Trajectory: Prices are expected to decline gradually over the next 2-3 years, with potential sharp decreases upon patent cliff.
- Supply Chain Risks: Manufacturing and raw material constraints can temporarily inflate prices but are unlikely to alter long-term trends significantly.
- Strategic Focus: Lifecycle management, geographic expansion, and differentiation through therapeutic innovation can mitigate revenue impacts.
- Regulatory Environment: Evolving policies around biosimilars and value-based pricing strategies will shape pricing and reimbursement landscapes.
FAQs
1. When is patent expiry for NDC 31722-0714?
Patent data indicates expiration around [specific date or estimated year], which likely will permit generic entrants within the subsequent [timeframe].
2. How will generic entry affect the drug's price?
Historically, generic competition causes a [percentage] price reduction within 12-24 months post-patent expiry, potentially reducing price per unit by [expected percentage].
3. Are there any upcoming regulatory decisions impacting the drug?
Pending FDA label expansions or approvals could influence demand and pricing, though no significant decisions are currently scheduled.
4. What factors could sustain higher prices longer-term?
Limited market competition due to manufacturing complexities, supply chain constraints, or ongoing exclusive rights could temporarily maintain higher prices.
5. How does market penetration influence future price projections?
Greater acceptance and formulary inclusion increase volume, which can temporarily offset declining unit prices, maximizing revenues until generics dominate.
Sources
- FDA Drugs@FDA Database. https://www.accessdata.fda.gov/scripts/cder/daf/
- IQVIA. (2022). U.S. Prescription Drug Market Analysis.
- Medicaid and Medicare Pricing Reports, CMS. (2022).
- Patent and Exclusivity Data, Orange Book. (2022).
- Industry analyst reports, [relevant financial and healthcare research firms].
Note: Specific product details like drug name, manufacturer, and approval status should be incorporated upon identification of the corresponding active ingredient and marketed brand.
