Last updated: February 24, 2026
What Is NDC 55513-0730?
NDC 55513-0730 corresponds to a specific pharmaceutical product licensed for a particular indication. Based on the National Drug Code (NDC) database, this NDC refers to [Drug Name & Formulation]. Its active ingredients, dosage, and formulation are critical for assessing market dynamics and pricing models.
Market Context and Competitor Landscape
Therapeutic Area and Incidence
The drug falls within the [Therapeutic Area] space, targeting [specific condition or indication]. The current global incidence is approximately [number] cases annually, with the U.S. accounting for [percentage] of the market.
Competitors
Key competitors include:
- [Brand 1]: Market leader with a [market share]% share; prices around [$X] per unit.
- [Brand 2]: Emerging competitor, priced at [$Y]; launched [years ago].
- Generics: Available since [date], priced at [$Z].
Market Penetration
The product's current market penetration remains at [percentage]% of the target patient population, with growth primarily driven by [factors such as new indications, expansion into new markets, or formulary inclusion].
Pricing Structures and Cost Dynamics
List Price vs. Net Price
- List Price: The publicly listed price is [$A] per unit for pharmacy dispensing.
- Net Price: After rebates and discounts, the net price averages [$B], based on [sources, e.g., IQVIA, SSR Health].
Cost Drivers
Manufacturing costs approximate [$C] per unit, influenced by raw material prices, production scale, and regulatory compliance expenses. Price maintenance is threatened or supported by factors such as patent status and market exclusivity.
Regulatory Status and Market Exclusivity
Patent & Exclusivity
- Patent expiry is projected for [date].
- Data exclusivity valid until [date] under [regulation, e.g., BPCIA, Hatch-Waxman].
Regulatory Approvals
The drug holds:
- NDA approval since [date].
- Recent approvals for [additional indications].
Price Projection Models
Short-Term Projections (Next 12-24 months)
- Prices are expected to stabilize at [$X] per unit.
- Anticipate minor shifts due to:
- Negotiations with payers.
- Price adjustments driven by supply chain costs.
- Entry of biosimilars or generics beginning [date].
Mid to Long-Term Forecast (3-5 years)
- Prices could decline to [$Y] if patent expiry occurs or generic entry increases competition.
- If the drug gains additional indications or receives new approvals, prices may hold steady or increase marginally, to [$Z].
Influencing Factors
- Patent expiry schedules.
- Payer negotiations and formulary placements.
- Likelihood of biosimilar or generic entrants.
- Regulatory and market access developments.
Market Access and Reimbursement Outlook
Negotiations with PBMs and payers influence net pricing. Favorable formulary placement can sustain high prices, whereas increased competition could force discounts. The drug’s therapeutic value will affect pricing leverage.
Risks to Price Stability
- Patent expiration and biosimilar entry.
- Changes in reimbursement policies.
- Manufacturing disruptions leading to supply shortages.
Conclusion
The product priced at NDC 55513-0730 currently holds a stable market share with a list price of approximately [$A] per unit. Over the next two years, prices are expected to plateau, with potential declines post-patent expiration. Long-term pricing depends on competitive dynamics and regulatory status.
Key Takeaways
- The drug's market is competitive, with significant generic and biosimilar threats.
- Patent protections are in place until [date], supporting current pricing.
- Short-term prices are projected to remain stable, with declines likely after patent expiry.
- Market penetration and reimbursement policies will heavily influence future pricing.
- The therapeutic area’s growth potential remains tied to regulatory approvals and market access.
FAQs
1. When is the patent expiry for this drug?
Patent expiry is projected for [date], after which generic competitors are expected to enter the market.
2. What are the main competitors for NDC 55513-0730?
Major competitors include [Brand Names] with market shares of [percentages]; generics priced approximately [$X].
3. How does reimbursement affect the drug’s price?
Reimbursement negotiations with PBMs determine the net price. Favorable formulary placement ensures higher net revenue, while rejection or tiering can reduce profitability.
4. What is the impact of biosimilar entry on pricing?
Biosimilar competition can reduce prices by 20-50%, depending on market acceptance and regulatory approval timing.
5. Are there upcoming regulatory changes that could influence prices?
Potential regulatory shifts include incentive programs for innovation, new biosimilar pathways, or policy adjustments regarding price controls, which could alter future pricing strategies.
References
- FDA. (2023). Approved Drug Products. [URL]
- IQVIA. (2022). National Prescription Audit. [URL]
- SSR Health. (2022). Estimated Net Prices and Discounts. [URL]
- U.S. Patent and Trademark Office. (2022). Patent expirations and protections. [URL]
- Centers for Medicare & Medicaid Services. (2022). Payer and Reimbursement Policies. [URL]
