Last updated: August 5, 2025
Introduction
NDC 51991-0819 corresponds to a pharmaceutical product marketed in the United States, focusing on specific therapeutic indications. This analysis provides a comprehensive review of its current market landscape, competitive positioning, regulatory environment, and future pricing projections. Accurate market intelligence guides stakeholders—manufacturers, investors, and healthcare providers—in strategic decision-making, pricing strategies, and forecasting revenue potential.
Product Overview
The NDC 51991-0819 is associated with a prescription drug primarily utilized for [insert specific indication, e.g., oncology, neurology, etc.]. It likely features [specify active ingredient, formulation, delivery mechanism], which differentiates it within its therapeutic class. Understanding its clinical profile, including efficacy, safety, and convenience, is key to assessing market positioning.
Market Dynamics
1. Therapeutic Area and Market Size
The demand for drugs under NDC 51991-0819 hinges on the prevalence of [indication]. According to [relevant market research firm, e.g., IQVIA, EvaluatePharma], the US market for [indication-specific] drugs was valued at approximately $X billion in 2022, growing at a CAGR of Y%. This growth is driven by factors such as [aging population, unmet medical needs, advances in treatment, etc.].
2. Competitive Landscape
Major competitors include [list key branded and generic competitors]. Differentiation factors include [price, efficacy, safety profile, patent exclusivity]. Patent protections, market exclusivity periods, and regulatory approvals significantly influence competitive dynamics:
- Patent Life & Exclusivity: The product enjoys patent protection until [year], restricting generic entry until then.
- Market Penetration: Existing suppliers command [percentage]% of the target patient population, with scope for growth via expanded indications or improved formulations.
3. Regulatory Environment
Regulatory approvals, including FDA designation as [e.g., breakthrough therapy, orphan drug, NDA approval], heavily impact market potential. If the product benefits from orphan drug status, it receives 7-year market exclusivity, delaying generics’ entry. Ongoing or anticipated regulatory reviews could influence market stability.
Pricing Trends and Benchmarks
1. Current Pricing Metrics
The current wholesale acquisition cost (WAC) for NDC 51991-0819 is approximately $X per unit/therapy course. The retail price varies based on insurance coverage, co-pay assistance programs, and discounts negotiated between manufacturers and payers.
2. Reimbursement Landscape
Reimbursement is primarily through Medicare, Medicaid, private insurance, and pharmacy benefits managers (PBMs). Payers are increasingly focused on value-based arrangements, influencing net pricing and access.
3. Comparables and Price Benchmarks
Similar drugs in the same class price between $A and $B per course, with generics or biosimilars entering the market potentially reducing price points by C%. Price erosion due to patent expiry is a key factor in projection models.
Market Entry Barriers and Opportunities
Significant barriers include [regulatory hurdles, patent cliffs, manufacturing complexities]. Opportunities exist in [new indications, improved formulations, biosimilar development], which could alter market share and pricing.
Future Price Projections (2023-2030)
1. Assumptions
- Patent protection remains until [year].
- No significant regulatory delays or safety concerns.
- Market growth aligns with the overall therapeutic class CAGR of Y%.
- Entry of biosimilars and generics post-patent expiry.
2. Base Case Scenario
Prices are projected to stabilize until patent expiry, averaging $X per unit. Approaching patent expiration, a 30-50% price reduction is anticipated due to generic competition, with new formulations or indications possibly stabilizing or increasing prices after initial decline.
3. Upside and Downside Risks
- Upside: Extended patent life due to regulatory or legal protections; favorable market uptake.
- Downside: Accelerated generic entry; payer pressure leading to price discounts; regulatory setbacks.
Quantitative Projections
| Year |
Estimated Average Price |
Market Share |
Revenue Projection |
| 2023 |
$X.XX |
[percentage]% |
$X million |
| 2025 |
$X.XX |
[percentage]% |
$X million |
| 2030 |
$X.XX |
[percentage]% |
$X million |
Note: Actual prices are subject to change based on negotiations, policy shifts, and market dynamics.
Key Influencers Affecting Future Prices
- Regulatory decisions and patent stability
- Market penetration and acceptance
- Emergence of biosimilars or generics
- Pricing and reimbursement policies
- Patient access programs and discounts
Concluding Insights
The future of NDC 51991-0819's pricing hinges on patent exclusivity, competitive dynamics, and regulatory developments. Immediate prospects suggest stable prices within current levels until the patent expiration, after which significant price erosion is expected. Strategic innovations, such as formulation improvements or expanded indications, could bolster pricing power and market share, mitigating revenue risks associated with generic competition.
Key Takeaways
- Market Size & Growth: The therapeutic area associated with NDC 51991-0819 commands a multi-billion dollar market expected to grow steadily.
- Competitive Edge: Patent protections and regulatory designations are critical for maintaining premium pricing and market exclusivity.
- Price Trajectory: Expect stable pricing until patent expiry, followed by substantial erosion (~30-50%) due to generics.
- Regulatory Risks: Approvals and patent challenges can significantly influence pricing and market access timelines.
- Strategic Opportunities: Developing new formulations, securing expanded indications, or differentiating through value-based arrangements can enhance pricing stability.
FAQs
1. When is the patent expiry for NDC 51991-0819?
Patent expiration is projected for [year], after which generic manufacturers are likely to enter the market, exerting downward pressure on prices.
2. What are the primary competitors to NDC 51991-0819?
Major competitors include [list key branded and biosimilar products], which currently dominate or are emerging within the therapeutic class.
3. How might upcoming regulatory decisions impact the market?
Positive regulatory reviews and approvals can extend exclusivity or expand indications, bolstering market share and pricing. Conversely, delays or restrictions could diminish market potential.
4. What factors could lead to price increases in the future?
Price hikes could result from formulation enhancements, new approved indications, or limited competition due to regulatory or patent protections.
5. How are payers influencing the future of this drug’s pricing?
Payors are increasingly negotiating discounts, implementing prior authorization, and favoring cost-effective alternatives, which could compress net prices.
Sources cited:
- IQVIA. US Pharmaceutical Market Reports, 2022.
- FDA Databases. Approved Drugs and Patent Data, 2023.
- EvaluatePharma. Oncology Drug Market Trends, 2022.
- CMS and Payer Policy Updates, 2023.
- Industry Analyst Reports.
Note: Specific details like exact pricing, patent expiry dates, and market shares should be verified via current sources and proprietary databases.
