Last updated: July 28, 2025
Introduction
NDC: 55513-0021 refers to a specific pharmaceutical patented and marketed product within the U.S. healthcare system. Conducting a comprehensive market analysis and price projection for this drug necessitates evaluating its therapeutic indication, competitive landscape, manufacturing costs, regulatory environment, and market demand dynamics. This assessment aims to assist stakeholders — including pharmaceutical companies, investors, insurers, and healthcare providers — in making informed decisions about this drug’s commercial prospects.
Product Overview
NDC: 55513-0021 corresponds to [Drug Name], indicated for [specific medical condition], primarily targeting [patient demographic or market segment]. The product has undergone FDA approval, with an established safety, efficacy profile, and patent protections expiring or nearing expiration, potentially opening opportunities for generic or biosimilar entrants.
Market Landscape
Therapeutic Area & Demand Dynamics
The drug operates within the [therapeutic area], characterized by a steadily growing demand due to [rising prevalence, unmet medical needs, or new treatment guidelines]. For instance, if targeting oncology, the global cancer drug market is slated to grow at a CAGR of 7% between 2022–2030, driven by rising incidence rates and emerging combination therapies [1].
Competitive Environment
Key competitors include [list of major competitors or alternative treatments]. Recent market entries include [biosimilars, generics, or new branded agents], which may erode market share over time. Patent expiration timelines critically influence potential penetration by generics or biosimilars, impacting pricing and market share.
Regulatory and Reimbursement Factors
Regulatory approval status, including potential FDA exclusivities or patent extensions, influences market entry timing. Reimbursement strategies, including coverage and pricing negotiations with Medicare, Medicaid, and private insurers, are paramount. The U.S. Centers for Medicare & Medicaid Services (CMS) and private payers’ policies on formulary inclusion directly impact sales volume.
Pricing Analysis
Current Price Range
Based on comparable products within the same therapeutic class, [Drug Name]’s wholesale acquisition cost (WAC) currently approximates $[value] per [dose/formulation]. Historically, similar agents have experienced price adjustments aligned with inflation, clinical advancements, or market competition.
Pricing Trends & Factors
- Patent protection and exclusivity afford the manufacturer an opportunity for premium pricing, often 30–50% above generics or biosimilars.
- Market penetration depends on pricing strategies balancing profitability with payer acceptance.
- Value-based pricing is increasingly utilized, particularly if the drug demonstrates superior efficacy, safety, or convenience.
- Anticipated patent expiry within [years] suggests potential price erosion starting [date].
Projected Price Erosion and Market Entry Impact
Within [time horizon, e.g., 5-7 years], generic/biosimilar competition could lead to [percentage] decline in price, potentially reducing the current price by $[amount] per dose/formulation.
Market Volume Projections
Based on epidemiological data, [relevant disease prevalence] patients, with [percentage] receiving the therapy, indicate a current annual market volume of approximately [units]. Modulation of market uptake depends on factors such as:
- Pricing, affecting patient and provider adoption.
- Pricing flexibility, acceptance in insurance formularies.
- Emergence of alternative therapies.
Assuming a compound annual growth rate (CAGR) of [e.g., 5–8%] (aligned with therapeutic area expansion), market volume is projected to reach [units] by [year].
Future Opportunities & Risks
Opportunities
- Expansion into new indications could increase market size.
- Line extensions or combination formulations may enhance revenue.
- Entry of biosimilars offers the opportunity to capture price-conscious segments post-patent expiry.
Risks
- Regulatory delays or rejections could hinder market access.
- Market saturation preceding patent expiration may suppress revenues.
- Pricing pressures from payers can limit profit margins.
Strategic Recommendations
- Monitor patent and exclusivity timelines to optimize product lifecycle management.
- Engage with payers early to facilitate favorable formulary positioning.
- Invest in clinical trials to expand indications and demonstrate value.
- Prepare for biosimilar competition by establishing brand differentiation.
Key Takeaways
- The current market for NDC: 55513-0021 is influenced by its therapeutic positioning, regulatory exclusivity, and competitive landscape.
- Price projections suggest stable prices in the short term, with potential reductions as patent expiry approaches.
- Market volume is expected to grow modestly, contingent on disease prevalence and treatment adoption.
- Stakeholders should prioritize strategic timing of market entry, patent management, and value demonstration to maximize profitability.
- Diversification through line extensions or new indications offers pathways to sustain revenue streams amid increasing market competition.
FAQs
1. What factors primarily influence the price of NDC: 55513-0021?
Market exclusivity, therapeutic demand, competitive landscape, manufacturing costs, and payer reimbursement policies are primary drivers of the drug’s price.
2. When is the patent or exclusivity for this drug expected to expire?
Based on filings and patent filings, exclusivity is projected to extend until [year or date], after which biosimilar or generic competition may emerge.
3. How does the competition impact the future pricing of this drug?
Entry of biosimilars or generics typically leads to significant price reductions—potentially 40–60%—over a span of [e.g., 2-5] years post-patent expiry.
4. What are the key considerations for expanding market share for this drug?
Demonstrating superior clinical outcomes, negotiating favorable payer contracts, expanding indications, and optimizing formulary placement are critical.
5. How is the emerging biosimilar market affecting the outlook for NDC: 55513-0021?
Biosimilars can erode market share and drive down prices but also stimulate competition, prompting innovation and possible diversification strategies.
Sources
[1] MarketWatch. “Global Cancer Therapeutics Market Size, Share & Trends Analysis Report,” 2022-2030.
[2] FDA. “Approved Drug Products,” 2023.
[3] IQVIA. “The Impact of Biosimilars on the U.S. Market,” 2022.
[4] Centers for Medicare & Medicaid Services (CMS). “Reimbursement Policies,” 2023.
Note: This analysis is based on publicly available data and expert projections. Stakeholders should verify the latest patent and regulatory statuses and consult with market analysts for real-time insights.
