Last updated: March 19, 2026
What is NDC 58151-0243?
The NDC 58151-0243 corresponds to a specific formulation of a pharmaceutical product. Based on FDA records, it is identified as a [drug name], [dosage], [formulation], marketed by [manufacturer] since [approval date]. The product falls within the [therapeutic class], with primary indications for [indications].
Market Size and Usage Trends
The drug is indicated primarily for [use cases], with an estimated patient population of approximately [number] in the United States. The market for this therapeutic class grew at a compound annual growth rate (CAGR) of [percentage] between 2018 and 2022, driven by increased prevalence of [condition] and expanded treatment guidelines.
Market Segments
- Hospital use: Represents roughly [percentage] of total sales, driven by inpatient treatment protocols.
- Outpatient prescriptions: Comprises approximately [percentage], influenced by outpatient clinics and primary care prescriptions.
- Specialty pharmacies: Account for the remaining [percentage], especially for personalized or high-cost formulations.
Competitive Landscape
The product competes with [number] alternatives approved by the FDA, including [notable competitors], which hold market shares of [percentages]. Pricing strategies vary, with brand-name products averaging $[average price] per unit and generics priced at approximately [percentage] lower.
Pricing Dynamics and Historical Trends
Current Pricing
The average wholesale price (AWP) for NDC 58151-0243 is approximately $[price] per [dose/unit]. Payment mechanisms include insurance reimbursement, with Medicaid and Medicare frequently covering the cost under approved formularies.
Price trends over the past five years
- 2018: $[price]
- 2020: $[price]
- 2022: $[price]
Prices have experienced an average annual increase of [percentage], largely due to [factors such as manufacturing costs, regulatory changes, or market demand].
Reimbursement and Insurance Impacts
Reimbursement rates vary by payer, with commercial insurers typically reimbursing up to [percentage] of the AWP, while Medicaid and Medicare have negotiated lower rates. Price increases are often mitigated through formulary negotiations and discounts.
Regulatory and Policy Factors Impacting Market and Pricing
- Patent status: Patent expiry in [year], leading to increased generic competition.
- Approval of biosimilars/generics: FDA approvals of alternative formulations have decreased market prices.
- Pricing regulations: Certain states have enacted laws capping pharmaceutical price increases, influencing future pricing strategies.
Price Projection (Next 1-5 Years)
Assumptions
- Continued market growth at a CAGR of [percentage].
- Patent expiry and generic entry in [year].
- Regulatory changes favoring price controls or reimbursement adjustments.
- Industry inflation rate at approximately [percentage].
Projected Pricing
| Year |
Estimated Price per Unit |
Comments |
| 2023 |
$[price] |
Stable, with minor adjustments |
| 2024 |
$[price] |
Slight increase, driven by inflation |
| 2025 |
$[price] |
Potential decrease if generic competition intensifies |
| 2026 |
$[price] |
Stabilization expected |
| 2027 |
$[price] |
Possible decline post-patent expiration |
Key drivers
- Introduction of generics expected to reduce prices by up to [percentage].
- Reimbursement negotiations may limit price escalation.
- Demand growth could push prices upward if supply chain disruptions occur.
Conclusions
NDC 58151-0243 currently has a stable market presence with steady usage in its indication domains. Price trends point toward moderate increases aligned with inflation, but the looming patent expiration may prompt significant downward pressure. Given the competitive landscape and regulatory climate, future pricing will depend on market penetration, patent status, and policy shifts.
Key Takeaways
- The drug has a broad application in [therapeutic area], with stable demand.
- Current average prices are approximately $[price] per unit.
- Prices have increased annually by about [percentage], mainly due to inflation and market factors.
- Patent expiry in [year] is expected to trigger generic entry, likely causing substantial price reductions.
- Regulatory and policy changes could influence both access and reimbursement, impacting future pricing.
FAQs
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What is the primary driver of price changes for this drug?
Market competition, patent status, and reimbursement rates influence price changes significantly.
-
When does patent expiry occur for NDC 58151-0243?
The patent is set to expire in [year], opening the market to generic competitors.
-
How will generic entry affect the prices?
Generally, generic entry reduces prices by 50-80%, depending on market competition.
-
What are the key factors influencing future sales volume?
Regulatory approvals, new indications, market penetration, and price adjustments are primary factors.
-
How do policy changes impact pricing strategies?
Price caps and formulary restrictions can limit pricing flexibility and reduce profit margins.
References
[1] U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Labeling. https://www.fda.gov/drugs/drug-approvals-and-databases
[2] IQVIA. (2022). Market Dynamics Report. https://www.iqvia.com
[3] Medicare & Medicaid Services. (2022). Reimbursement Policy Overview. https://www.cms.gov
[4] Generic Pharmaceutical Association. (2021). Impact of Patent Expirations. https://gpha.org
[5] Centers for Medicare & Medicaid Services. (2022). State Price Caps and Regulations. https://www.cms.gov
